Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:34 PM
Study NCT ID:
NCT07421895
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Multicenter Observational Real-world Study of Retained Products of Conception
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014619', 'term': 'Vacuum Curettage'}], 'ancestors': [{'id': 'D004107', 'term': 'Dilatation and Curettage'}, {'id': 'D003475', 'term': 'Curettage'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-10', 'size': 304452, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-11T22:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment', 'timeFrame': 'At 3 months after completion of treatment (on the 16th-24th day of the third menstrual cycle post-treatment)', 'description': 'Intrauterine adhesions are diagnosed by three-dimensional transvaginal ultrasound or hysteroscopy. Adhesions are graded according to the American Fertility Society (AFS) classification. This outcome measures the incidence of IUA following different management strategies for retained products of conception, reflecting the degree of endometrial injury.'}, {'measure': 'Number of Participants Requiring Secondary Surgical Evacuation', 'timeFrame': 'From initiation of treatment to 3 months post-treatment', 'description': 'Secondary surgical evacuation is defined as any additional surgical procedure (hysteroscopic or curettage) required for complete removal of retained products of conception after the initial management strategy. This outcome reflects the effectiveness of the initial treatment approach and the number of intrauterine procedures.'}, {'measure': 'Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception', 'timeFrame': 'From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year', 'description': 'Pregnancy is defined as a positive serum β-hCG test and confirmed intrauterine gestational sac by ultrasound. This outcome is assessed only in participants with fertility intent and reflects the ultimate goal of fertility preservation.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Active Bleeding During Expectant Management', 'timeFrame': 'From enrollment to hospitalization or intervention, assessed up to 3 months', 'description': 'Active bleeding is defined as vaginal bleeding exceeding twice the normal menstrual volume, requiring emergency hospitalization or surgical intervention during the expectant management period. This outcome reflects the safety of expectant management.'}, {'measure': 'Number of Participants with Pelvic Infection During Expectant Management', 'timeFrame': 'From enrollment to hospitalization or intervention, assessed up to 3 months', 'description': 'Pelvic infection is defined as the presence of clinical signs (fever, pelvic pain, purulent discharge) and/or laboratory evidence (elevated white blood cell count, CRP, procalcitonin) requiring antibiotic therapy or surgical intervention. This outcome reflects the safety of expectant management.'}, {'measure': 'Number of Participants with Live Birth Following Subsequent Pregnancy', 'timeFrame': 'At delivery, assessed up to 1 year after pregnancy confirmation', 'description': 'Live birth is defined as the delivery of any viable infant (≥24 weeks of gestation). This outcome is the most definitive measure of reproductive outcome following treatment.'}, {'measure': 'Intraoperative Blood Loss During Hysteroscopic Surgery', 'timeFrame': 'During the surgical procedure', 'description': 'Estimated blood loss (in mL) during hysteroscopic removal of retained products of conception. This outcome reflects surgical complexity and the invasiveness of the procedure.'}, {'measure': 'Endometrial Thickness at 3 Months Post-Treatment', 'timeFrame': 'At 3 months after treatment (on the 16th-24th day of the third menstrual cycle post-treatment)', 'description': 'Endometrial thickness (in mm) measured by three-dimensional transvaginal ultrasound during the mid-luteal phase. This outcome serves as a surrogate marker of endometrial recovery and receptivity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retained Products of Conception', 'RPOC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the optimal treatment strategy for retained products of pregnancy. Compared with surgical treatment, prospectively observe whether drug-assisted expectant management until the right time for surgery reduce the occurrence of intrauterine adhesions, and thus protect fertility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'From June 2022 to June 2024, patients diagnosed with retained products of conception by ultrasound in the outpatient department.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Clinical diagnosis of retained products of conception, and ultrasound indicated that the maximum diameter of the lesion ≥0.5cm.\n\nExclusion Criteria:1) There is active bleeding requiring immediate surgical intervention;2) combined with obvious infection;3) Combined with severe organ dysfunction, including coagulation dysfunction.'}, 'identificationModule': {'nctId': 'NCT07421895', 'briefTitle': 'A Prospective Multicenter Observational Real-world Study of Retained Products of Conception', 'organization': {'class': 'OTHER', 'fullName': 'The Third Xiangya Hospital of Central South University'}, 'officialTitle': 'A Prospective Multicenter Observational Real-world Study of Retained Products of Conception', 'orgStudyIdInfo': {'id': 'fkky2022001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'After the patient is confirmed to be included in the study, he/she will be hospitalized directly and will undergo hysteroscopic removal of pregnancy products.', 'interventionNames': ['Procedure: Uterine curettage']}, {'label': 'Experimental group', 'description': 'Wait until a certain time, then surgical treatment if necessary', 'interventionNames': ['Drug: Expectant care']}], 'interventions': [{'name': 'Uterine curettage', 'type': 'PROCEDURE', 'description': 'Use intravenous general anesthesia (which can be assisted by laryngeal mask) (local anesthesia, epidural anesthesia or endotracheal intubation anesthesia can be selected in special cases), the patient takes the lithotomy position, the anesthesia effect is satisfactory, and the uterine distension fluid is normal saline. The uterine distension pressure is adjusted to maintain at 100-120 mmHg. It is recommended to use a diagnostic and therapeutic integrated hysteroscope with an outer diameter of \\<5 mm (it is necessary to record the specific type of hysteroscope and instrument used) to enter the uterine cavity through the cervix to clarify the situation in the uterine cavity. Then explore the depth of the uterus. (Under ultrasonic monitoring) The cervical dilator sequentially dilates the cervix to 8-10 (depending on the outer diameter of the therapeutic hysteroscope used, hysteroscopic electroresection is not recommended), and select a 7mm outer diameter hysteroscope with a 3mm diameter.', 'armGroupLabels': ['Control group']}, {'name': 'Expectant care', 'type': 'DRUG', 'description': 'Patients with no contraindications to medication should take 2mg Bid of Progynova (or a similar dose of Estoril) orally until after surgery (generally, Progynova is still used for about 2-4 weeks after surgery and progesterone withdrawal bleeding is used); take Yimucao granules or Wujia Biochemical Capsules orally for 2 weeks and then stop taking the medicine; check blood β-HCG every week; check uterine and bilateral adnexa 4D color Doppler ultrasound every 2-3 weeks; until the preset surgery time is reached: 1) blood β-HCG \\<50mmol/L; 2) B-ultrasound measurement of the length from the internal cervical os to the uterine fundus ≤6cm; 3) the time interval from the previous surgery is at least 4 weeks; 4) Color Doppler ultrasound indicates that the blood flow level of the pregnancy and the attachment is 1-3.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dabao MD', 'role': 'CONTACT', 'email': 'forxudabao@126.com', 'phone': '13017386201'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Dabao MD', 'role': 'CONTACT', 'email': 'forxudabao@126.com', 'phone': '13017386201'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Changsha Hospital for Maternal and Child Health Care', 'class': 'OTHER'}, {'name': 'ZhuZhou Central Hospital', 'class': 'OTHER'}, {'name': 'Xiangtan Central Hospital', 'class': 'OTHER'}, {'name': 'Xiangtan Hospital for Maternal and Child Health Care', 'class': 'UNKNOWN'}, {'name': 'Yiyang Hospital for Maternal and Child Health Care', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of YueYang", 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Changde City", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Shaoyang University', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Huaihua", 'class': 'UNKNOWN'}, {'name': 'Hengyang Central Hospital', 'class': 'OTHER_GOV'}, {'name': 'Chenzhou Hospital for Maternal and Child Health Care', 'class': 'UNKNOWN'}, {'name': 'Yongzhou Center Hospital', 'class': 'UNKNOWN'}, {'name': "Hunan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Changsha Maternal and Child Health Hospital', 'class': 'UNKNOWN'}, {'name': "Liuyang People's Hospital", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xu dabao', 'investigatorAffiliation': 'The Third Xiangya Hospital of Central South University'}}}}