Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-04-22 @ 5:53 AM
Study NCT ID:
NCT02738892
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zambian Preterm Birth Prevention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, vaginal, placental, and umbilical cord samples will be placed in a biorepository for later analysis to identify inflammatory markers, chemokines, cytokines, and infections contributing to parturition and preterm delivery.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm Birth <37', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of deliveries occurring prior to 37 weeks gestation'}], 'secondaryOutcomes': [{'measure': 'Preterm Birth <34', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of deliveries occurring prior to 34 weeks gestation'}, {'measure': 'Preterm Birth <28', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of deliveries occurring prior to 28 weeks gestation'}, {'measure': 'Low Birth Weight', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of newborns weighing less than 2500 grams at delivery'}, {'measure': 'Very Low Birth Weight', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of newborns weighing less than 1500 grams at delivery'}, {'measure': 'Preterm prelabor rupture of membranes (PPROM)', 'timeFrame': 'Enrollment through delivery', 'description': 'Proportion of women with PPROM'}, {'measure': 'Spontaneous delivery prior to 37 weeks of gestation', 'timeFrame': 'Enrollment through 37 weeks gestation', 'description': 'Proportion of spontaneous deliveries'}, {'measure': 'Spontaneous delivery prior to 34 weeks of gestation', 'timeFrame': 'Enrollment through 34 weeks gestation', 'description': 'Proportion of spontaneous deliveries'}, {'measure': 'Spontaneous delivery prior to 28 weeks of gestation', 'timeFrame': 'Enrollment through 28 weeks gestation', 'description': 'Proportion of spontaneous deliveries'}, {'measure': 'Birth weight <10th percentile for gestational age', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of newborns with birth weight \\< 10th percentile for gestational age'}, {'measure': 'Birth weight <3rd percentile for gestational age', 'timeFrame': 'Measured at delivery', 'description': 'Proportion of newborns with birth weight \\<3rd percentile for gestational age'}, {'measure': 'Mother-to-child HIV transmission by 6 weeks postpartum', 'timeFrame': 'Delivery through 6 weeks postpartum', 'description': 'Proportion of HIV positive newborns'}, {'measure': 'Mother-to-child HIV transmission by 12 months postpartum', 'timeFrame': 'Delivery through 12 months postpartum', 'description': 'Proportion of HIV positive infants'}, {'measure': 'Maternal mortality', 'timeFrame': 'Enrollment through 12 months postpartum', 'description': 'Death of a maternal participant for any reason'}, {'measure': 'Fetal, neonatal, and infant mortality', 'timeFrame': 'Enrollment through 12 months postpartum', 'description': 'Death of a fetal, neonatal, or infant participant for any reason'}, {'measure': 'Infant APGAR scores', 'timeFrame': 'Measured at delivery', 'description': 'APGAR scores at delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Stillbirth', 'Preterm birth'], 'conditions': ['Pregnancy', 'Stillbirth', 'Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '22692417', 'type': 'BACKGROUND', 'citation': 'Lawn JE, Kinney MV, Black RE, Pitt C, Cousens S, Kerber K, Corbett E, Moran AC, Morrissey CS, Oestergaard MZ. Newborn survival: a multi-country analysis of a decade of change. Health Policy Plan. 2012 Jul;27 Suppl 3:iii6-28. doi: 10.1093/heapol/czs053.'}, {'pmid': '22866189', 'type': 'BACKGROUND', 'citation': 'Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5.'}, {'pmid': '15286219', 'type': 'BACKGROUND', 'citation': 'Wang ML, Dorer DJ, Fleming MP, Catlin EA. Clinical outcomes of near-term infants. Pediatrics. 2004 Aug;114(2):372-6. doi: 10.1542/peds.114.2.372.'}, {'pmid': '22682464', 'type': 'BACKGROUND', 'citation': 'Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.'}, {'type': 'BACKGROUND', 'citation': 'March of Dimes P, Save the Children, WHO. Born Too Soon: The Global Action Report on Preterm Birth. In. Edited by Eds CP Howson MK, JE Lawn. Geneva: World Health Organization; 2012.'}, {'pmid': '18177778', 'type': 'BACKGROUND', 'citation': 'Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.'}, {'pmid': '24219711', 'type': 'BACKGROUND', 'citation': 'Oliver RS, Lamont RF. Infection and antibiotics in the aetiology, prediction and prevention of preterm birth. J Obstet Gynaecol. 2013 Nov;33(8):768-75. doi: 10.3109/01443615.2013.842963.'}, {'pmid': '19951079', 'type': 'BACKGROUND', 'citation': 'Gotsch F, Gotsch F, Romero R, Erez O, Vaisbuch E, Kusanovic JP, Mazaki-Tovi S, Kim SK, Hassan S, Yeo L. The preterm parturition syndrome and its implications for understanding the biology, risk assessment, diagnosis, treatment and prevention of preterm birth. J Matern Fetal Neonatal Med. 2009;22 Suppl 2:5-23. doi: 10.1080/14767050902860690. No abstract available.'}, {'pmid': '15752534', 'type': 'BACKGROUND', 'citation': 'Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.'}, {'pmid': '24428470', 'type': 'BACKGROUND', 'citation': 'Iams JD. Clinical practice. Prevention of preterm parturition. N Engl J Med. 2014 Jan 16;370(3):254-61. doi: 10.1056/NEJMcp1103640. No abstract available.'}, {'pmid': '20147718', 'type': 'BACKGROUND', 'citation': 'Muglia LJ, Katz M. The enigma of spontaneous preterm birth. N Engl J Med. 2010 Feb 11;362(6):529-35. doi: 10.1056/NEJMra0904308. No abstract available.'}, {'pmid': '20348884', 'type': 'BACKGROUND', 'citation': 'Kim CJ, Romero R, Kusanovic JP, Yoo W, Dong Z, Topping V, Gotsch F, Yoon BH, Chi JG, Kim JS. The frequency, clinical significance, and pathological features of chronic chorioamnionitis: a lesion associated with spontaneous preterm birth. Mod Pathol. 2010 Jul;23(7):1000-11. doi: 10.1038/modpathol.2010.73. Epub 2010 Mar 26.'}, {'pmid': '22344727', 'type': 'BACKGROUND', 'citation': 'Myatt L, Eschenbach DA, Lye SJ, Mesiano S, Murtha AP, Williams SM, Pennell CE; International Preterm Birth Collaborative Pathways and Systems Biology Working Groups. A standardized template for clinical studies in preterm birth. Reprod Sci. 2012 May;19(5):474-82. doi: 10.1177/1933719111426602. Epub 2012 Feb 16.'}, {'pmid': '17206962', 'type': 'BACKGROUND', 'citation': 'Romero R, Espinoza J, Kusanovic JP, Gotsch F, Hassan S, Erez O, Chaiworapongsa T, Mazor M. The preterm parturition syndrome. BJOG. 2006 Dec;113 Suppl 3(Suppl 3):17-42. doi: 10.1111/j.1471-0528.2006.01120.x.'}, {'pmid': '17206980', 'type': 'BACKGROUND', 'citation': 'Romero R, Espinoza J, Gotsch F, Kusanovic JP, Friel LA, Erez O, Mazaki-Tovi S, Than NG, Hassan S, Tromp G. The use of high-dimensional biology (genomics, transcriptomics, proteomics, and metabolomics) to understand the preterm parturition syndrome. BJOG. 2006 Dec;113 Suppl 3(Suppl 3):118-35. doi: 10.1111/j.1471-0528.2006.01150.x.'}, {'pmid': '23858477', 'type': 'BACKGROUND', 'citation': 'Liong S, Di Quinzio MK, Fleming G, Permezel M, Rice GE, Georgiou HM. Prediction of spontaneous preterm labour in at-risk pregnant women. Reproduction. 2013 Aug 21;146(4):335-45. doi: 10.1530/REP-13-0175. Print 2013 Oct.'}, {'pmid': '3651732', 'type': 'BACKGROUND', 'citation': 'Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.'}, {'pmid': '12124409', 'type': 'BACKGROUND', 'citation': 'Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Jul 18;347(3):194-9. doi: 10.1056/NEJMcp011542. No abstract available.'}, {'pmid': '23360713', 'type': 'BACKGROUND', 'citation': 'Aleman A, Cafferata ML, Gibbons L, Althabe F, Ortiz J, Sandoval X, Padilla-Raygoza N, Belizan JM. Use of antenatal corticosteroids for preterm birth in Latin America: providers knowledge, attitudes and practices. Reprod Health. 2013 Jan 29;10:4. doi: 10.1186/1742-4755-10-4.'}, {'pmid': '10796110', 'type': 'BACKGROUND', 'citation': 'Crowley P. Prophylactic corticosteroids for preterm birth. Cochrane Database Syst Rev. 2000;(2):CD000065. doi: 10.1002/14651858.CD000065.'}, {'pmid': '36263879', 'type': 'DERIVED', 'citation': 'Appiagyei A, Vwalika B, Spelke MB, Conner MG, Mabula-Bwalya CM, Kasaro MP, Honart AW, Kumwenda A, Stringer EM, Stringer JSA, Price JT. Maternal mid-upper arm circumference to predict small for gestational age: Findings in a Zambian cohort. Int J Gynaecol Obstet. 2023 May;161(2):462-469. doi: 10.1002/ijgo.14517. Epub 2022 Oct 31.'}, {'pmid': '33587508', 'type': 'DERIVED', 'citation': 'Price JT, Vwalika B, Edwards JK, Cole SR, Kasaro MP, Rittenhouse KJ, Kumwenda A, Lubeya MK, Stringer JSA. Maternal HIV Infection and Spontaneous Versus Provider-Initiated Preterm Birth in an Urban Zambian Cohort. J Acquir Immune Defic Syndr. 2021 Jun 1;87(2):860-868. doi: 10.1097/QAI.0000000000002654.'}, {'pmid': '33394679', 'type': 'DERIVED', 'citation': 'Rittenhouse KJ, Mwape H, Nelson JAE, Mwale J, Chipili G, Price JT, Hudgens M, Stringer EM, De Paris K, Vwalika B, Stringer JSA. Maternal HIV, antiretroviral timing, and spontaneous preterm birth in an urban Zambian cohort: the role of local and systemic inflammation. AIDS. 2021 Mar 15;35(4):555-565. doi: 10.1097/QAD.0000000000002808.'}, {'pmid': '30811399', 'type': 'DERIVED', 'citation': 'Rittenhouse KJ, Vwalika B, Keil A, Winston J, Stoner M, Price JT, Kapasa M, Mubambe M, Banda V, Muunga W, Stringer JSA. Improving preterm newborn identification in low-resource settings with machine learning. PLoS One. 2019 Feb 27;14(2):e0198919. doi: 10.1371/journal.pone.0198919. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'http://www.unc.edu', 'label': 'University of North Carolina website'}]}, 'descriptionModule': {'briefSummary': 'This prospective non-intervention cohort study will enroll women in the first or early second trimester of pregnancy and follow them through delivery (or end of pregnancy) and 1 year postpartum.\n\nInfants will also be followed until 1 year postpartum. Detailed medical and obstetrical information will be collected, as well as biological samples, in order to better elucidate the biological mechanisms leading to preterm delivery among Zambian women, in an effort to identify new strategies for prevention.', 'detailedDescription': "After consenting to study participation, women will be asked their detailed medical and obstetrical history. Participants will be provided standard of care. Blood, urine, and vaginal specimens will also be collected for the biorepository from those who consent to participate. Participants will also be screened for depression using the Edinburgh Postnatal Depression Scale (EPDS).\n\nThroughout the study, participants will receive education about nutrition, pregnancy health, and the signs and symptoms of complications of pregnancy, including preterm labor and preterm premature rupture of membranes. Study visits for will be scheduled at 24, 28, 32, and 36 weeks gestation, at the time of discharge from the labor and delivery ward if possible, and at 7 days, 28 days, 42 days, 6 months, and 12 months postpartum\n\nDuring each study visit (i.e., at 24, 32, and 36 weeks gestation), participants will receive the routinely recommended screening and treatment. This will consist of weight, blood pressure, and symptom screening, as well as measurements of fetal growth (fundal height) and fetal well being (fetal heart rate) at each visit. Screening and treatment of common pregnancy complications will also be provided if clinically indicated. All participants will undergo maternal hemoglobin testing and urinalysis at the 24 and 32-week visits. Maternal random fasting glucose testing will be conducted at the 28-week visit to screen for gestational diabetes. Syphilis titers will be obtained at a minimum at the 36 week visit for participants seropositive at screening to monitor serologic response after treatment. HIV testing will be repeated at 28 weeks for participants uninfected at screening, and HIV Viral Load and T cell assays will be performed at the 28- and 36-week visits for any seroconverters. Participants who are HIV-infected at screening will undergo HIV Viral Load and T cell assays at 28 and 36 weeks. At 24, 28, and 36 weeks, blood, urine, oropharyngeal, and vaginal swabs will be collected. We will also collect a rectal swab at the 36-week visit. .\n\nAt the time of delivery, the study team will obtain detailed information about the clinical management of the participant's delivery, as well as the delivery outcome for both the mother and her infant(s). A urinalysis, complete blood count with differential, blood chemistry testing will be performed. We will also obtain information on interval complications and mortality. In addition, we will collect samples of the placenta, umbilical cord, and cord blood after delivery for various assessments. 4-5 drops of cord blood will be applied to designated filter paper within pre-printed circles. Newborn heel-prick samples will be collected 24-72 hours after birth or sooner if the newborn is discharged from hospital within 24 hours of delivery.\n\nThere will be four study visits during the postnatal period, at 7 days, 42 days, 6 months, and 12 months postpartum. At these visits, we will assess interval maternal or infant complications and/or mortality and measure anthropometrics. Once again, participants will receive routinely recommended screening and treatment.\n\nMaternal hemoglobin will be measured at all post-partum visits. Urinalysis will be performed at the 42-day visit only. Maternal blood, urine, oral/pharyngeal and vaginal specimens will be collected for storage and protocol related testing at the 42-day visit. Maternal syphilis and HIV testing will be repeated at the 42-day, 6- and 12-month visits for participants who are uninfected. HIV-exposed infants will have blood collected for early infant diagnosis at the 42-day and 6- and 12-month visits; this will be done via heel prick and dried blood spot (DBS) cards requiring five drops of blood. Maternal participants will again be screened for depression using the EPDS"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted at Kamwala Health Centre and the University Teaching Hospital, both in Lusaka, Zambia.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPregnant women ≥15 years will be eligible to participate. Additionally, participants will:\n\n1. Have a completed screening ultrasound with gestational age \\< 20 weeks\n2. Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 \\[3 Nov 2017\\] enrolled both HIV-infected and uninfected women)\n3. Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound\n4. Reside within Lusaka with no plans to relocate during the study follow-up period\n5. Be willing to provide written, informed consent\n6. Be willing to allow their infants to participate in the study\n\nExclusion criteria:\n\n1. Pregnant women \\> 24 weeks' gestation or with screening ultrasound ≥ 16 weeks\n2. Infants born to women not enrolled in the study"}, 'identificationModule': {'nctId': 'NCT02738892', 'acronym': 'ZAPPS', 'briefTitle': 'Zambian Preterm Birth Prevention Study', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Preventing Preterm Birth in Zambia', 'orgStudyIdInfo': {'id': '14-2113'}}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Kamwala Health Centre', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'city': 'Lusaka', 'country': 'Zambia', 'facility': 'University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Jeff Stringer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Global Alliance to Prevent Prematurity and Stillbirth', 'class': 'UNKNOWN'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}