Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-02-18 @ 1:16 PM
Study NCT ID:
NCT03862495
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2019-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D016358', 'term': 'Contact Tracing'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lichch8@mail2.sysu.edu.cn', 'phone': '18585239166', 'title': 'Deputy Chief Physician Li Changchang', 'organization': 'Skin Disease Hospital of Southern Medical University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Given the severity of the underlying illness, participants were expected to have adverse pregnancy outcomes. All adverse pregnancy outcomes were captured as Advere Events (AEs). In addition, all Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction was reported as an AE. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.', 'eventGroups': [{'id': 'EG000', 'title': 'Maternal Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 5, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fetus or Infant of Mother Receiving Chlamydia Screening and Treatment', 'description': 'Fetuses in utero or infants of mothers assigned chlamydia screening and treatment', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 21, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Maternal Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Fetus or Infant of Mother Receiving Control', 'description': 'Fetuses in utero or infants of mothers assigned control', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 22, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Adverse pregnancy outcomes', 'notes': 'Adverse pregnancy outcomes that were also listed as the main study outcomes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response Rate at Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the time of enrollment', 'description': 'Number of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compliance to Receive CT or NG Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 week after the notification of positive test results', 'description': 'Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of the 100 participants screened for each arm, 12 in the Chlamydia group tested positive and 3 in the Control group tested positive.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Considered as Cured After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 or 3 months after the treatment', 'description': 'Number of women who re-tested negative either at 1 or at 3 months after treatment divided by the number of women who received CT or NG treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of the 100 participants screened for each arm, 3 in the Chlamydia group were treated and 1 in the Control group was treated.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Pregnancy Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of any adverse pregnancy outcomes, including stillbirth (a baby who dies after 28 weeks of pregnancy, but before or during birth), fetal death, infant death, miscarriage (pregnancy loss between 12-28 weeks), preeclampsia (pre eclampsia: hypertension with proteinuria occurs after 20 weeks of pregnancy; eclampsia: convulsions that occur on the basis of preeclampsia and cannot be explained by other reasons), low birth weight (\\<2500g), smaller than gestational age, preterm birth (\\<37 gestational weeks), birth defect, and premature rupture of membrane (spontaneous rupture of fetal membranes before delivery, classified into full-term PROM and preterm PROM based on the gestational age) in both groups through study completion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Considered as Cured at 1 Month After the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month after the treatment', 'description': 'Number of women who get tested for CT and NG 1 month after the treatment divided by the number of women who receive CT or NG treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Considered Cured at 3 Months After the Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months after the treatment', 'description': 'Number of women who get tested for CT and NG 3 months after the treatment divided by the number of women who re-tested CT or NG positive at 1 month after the treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of People Who Completed Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'OG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of women who are followed-up by the end of pregnancy or in the event of adverse pregnancy outcomes divided the number of women who are enrolled at the recruitment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'FG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'BG001', 'title': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.\n\nC. trachomatis and N. gonorrhoeae: In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.\n\nAzithromycin: Azithromycin 1g administered as a single oral dose\n\nPartner notification and treatment: Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.72', 'spread': '0.533', 'groupId': 'BG000'}, {'value': '29.18', 'spread': '0.576', 'groupId': 'BG001'}, {'value': '29.45', 'spread': '0.392', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Premature rupture of membranes', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Premature delivery', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low birth weight', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pregnancy loss', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-12', 'size': 2256012, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-09T09:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2019-02-22', 'resultsFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-29', 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate at Recruitment', 'timeFrame': 'at the time of enrollment', 'description': 'Number of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment'}, {'measure': 'Compliance to Receive CT or NG Treatment', 'timeFrame': 'Within 1 week after the notification of positive test results', 'description': 'Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results'}, {'measure': 'Number of Participants Considered as Cured After Treatment', 'timeFrame': '1 or 3 months after the treatment', 'description': 'Number of women who re-tested negative either at 1 or at 3 months after treatment divided by the number of women who received CT or NG treatment'}, {'measure': 'Number of Participants With Adverse Pregnancy Outcomes', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of any adverse pregnancy outcomes, including stillbirth (a baby who dies after 28 weeks of pregnancy, but before or during birth), fetal death, infant death, miscarriage (pregnancy loss between 12-28 weeks), preeclampsia (pre eclampsia: hypertension with proteinuria occurs after 20 weeks of pregnancy; eclampsia: convulsions that occur on the basis of preeclampsia and cannot be explained by other reasons), low birth weight (\\<2500g), smaller than gestational age, preterm birth (\\<37 gestational weeks), birth defect, and premature rupture of membrane (spontaneous rupture of fetal membranes before delivery, classified into full-term PROM and preterm PROM based on the gestational age) in both groups through study completion.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Considered as Cured at 1 Month After the Treatment', 'timeFrame': '1 month after the treatment', 'description': 'Number of women who get tested for CT and NG 1 month after the treatment divided by the number of women who receive CT or NG treatment.'}, {'measure': 'Number of Participants Considered Cured at 3 Months After the Treatment', 'timeFrame': '3 months after the treatment', 'description': 'Number of women who get tested for CT and NG 3 months after the treatment divided by the number of women who re-tested CT or NG positive at 1 month after the treatment'}, {'measure': 'Number of People Who Completed Follow-up', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of women who are followed-up by the end of pregnancy or in the event of adverse pregnancy outcomes divided the number of women who are enrolled at the recruitment.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chlamydia Trachomatis Infection']}, 'descriptionModule': {'briefSummary': 'This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes.\n\nApproximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.', 'detailedDescription': 'Women recruited for the study will be randomized to the intervention or control groups. Women in the intervention group will be tested in real time for C. trachomatis and Neisseria gonorrhoeae. Patients who test positive for either infection will be linked to physicians at the Center for treatment. For the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. In the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. The endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn.\n\nQualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. University of North Carolina at Chapel Hill (UNC) investigators will work with the Nanhai Hospital of Southern Medical University and staff at Dermatology Hospital of Southern Medical University to oversee the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnant women on their first visit to the hospital (regardless of gestational age);\n2. aged 18 or above;\n3. agree to participate and sign an informed consent.\n\nExclusion Criteria:\n\n1. systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;\n2. comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);\n3. diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.'}, 'identificationModule': {'nctId': 'NCT03862495', 'acronym': 'RCT', 'briefTitle': 'Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study', 'orgStudyIdInfo': {'id': '18-1168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlamydia Screening and Treatment', 'description': 'At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.', 'interventionNames': ['Diagnostic Test: C. trachomatis and N. gonorrhoeae', 'Drug: Azithromycin', 'Other: Partner notification and treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.', 'interventionNames': ['Diagnostic Test: C. trachomatis and N. gonorrhoeae', 'Drug: Azithromycin', 'Other: Partner notification and treatment']}], 'interventions': [{'name': 'C. trachomatis and N. gonorrhoeae', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Roche Cobas Z480'], 'description': 'In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.', 'armGroupLabels': ['Chlamydia Screening and Treatment', 'Control']}, {'name': 'Azithromycin', 'type': 'DRUG', 'otherNames': ['Zithromax, Zmax'], 'description': 'Azithromycin 1g administered as a single oral dose', 'armGroupLabels': ['Chlamydia Screening and Treatment', 'Control']}, {'name': 'Partner notification and treatment', 'type': 'OTHER', 'description': 'Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses', 'armGroupLabels': ['Chlamydia Screening and Treatment', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Dermatology Hospital of Southern Medical Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanhai Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Weiming Tang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From December 2020 to May 2023', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Investigator who proposes to use the data should have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}