Zambian Preterm Birth Prevention Study

NCT02738892 | Active Not Recruiting

• 1 other identifier: 14-2113
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 2

Brief Summary

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. Infants 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.

Conditions

Pregnancy; Stillbirth; Preterm Birth

Keywords

Pregnancy; Stillbirth; Preterm birth

Outcome Measures

Primary Outcomes (1)

• Preterm Birth <37

  Proportion of deliveries occurring prior to 37 weeks gestation

  Measured at delivery

Secondary Outcomes (15)

• Preterm Birth <34

  Measured at delivery

• Preterm Birth <28

  Measured at delivery

• Low Birth Weight

  Measured at delivery

• Very Low Birth Weight

  Measured at delivery

• Preterm prelabor rupture of membranes (PPROM)

  Enrollment through delivery

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted at Kamwala Health Centre and the University Teaching Hospital, both in Lusaka, Zambia.

You may qualify if:

• Pregnant women ≥15 years will be eligible to participate. Additionally, participants will:
• Have a completed screening ultrasound with gestational age \< 20 weeks
• Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 \[3 Nov 2017\] enrolled both HIV-infected and uninfected women)
• Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound
• Reside within Lusaka with no plans to relocate during the study follow-up period
• Be willing to provide written, informed consent
• Be willing to allow their infants to participate in the study

You may not qualify if:

• Pregnant women \> 24 weeks' gestation or with screening ultrasound ≥ 16 weeks
• Infants born to women not enrolled in the study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Global Alliance to Prevent Prematurity and Stillbirth: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (2)

Kamwala Health Centre

Lusaka, Zambia

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (24)

• 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: 22692417 BACKGROUND

• Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5.

  PMID: 22866189 BACKGROUND

• 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: 15286219 BACKGROUND

• 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.

  PMID: 22682464 BACKGROUND

• 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.

  BACKGROUND

• 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: 18177778 BACKGROUND

• 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: 24219711 BACKGROUND

• 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: 19951079 BACKGROUND

• 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: 15752534 BACKGROUND

• 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: 24428470 BACKGROUND

• 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: 20147718 BACKGROUND

• 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: 20348884 BACKGROUND

• 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: 22344727 BACKGROUND

• 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: 17206962 BACKGROUND

• 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: 17206980 BACKGROUND

• 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: 23858477 BACKGROUND

• 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: 3651732 BACKGROUND

• 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: 12124409 BACKGROUND

• 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: 23360713 BACKGROUND

• Crowley P. Prophylactic corticosteroids for preterm birth. Cochrane Database Syst Rev. 2000;(2):CD000065. doi: 10.1002/14651858.CD000065.

  PMID: 10796110 BACKGROUND

• 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: 36263879 DERIVED

• 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: 33587508 DERIVED

• 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: 33394679 DERIVED

• 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.

  PMID: 30811399 DERIVED

Related Links

• University of North Carolina website

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Stillbirth; Premature Birth

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Jeff Stringer, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 14, 2016
• Study Start: August 1, 2015
• Primary Completion: October 5, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

ZA (2)