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PregnancyZAPPSNCT02738892

Zambian Preterm Birth Prevention Study

An observational study of Pregnancy and Stillbirth, run by University of North Carolina, Chapel Hill at 2 sites in Zambia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Stillbirth, Preterm Birth
How many people
9,000 participants
Where
2 sitesZambia
Study dates
Aug 2015to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Zambia2 sites

  • Kamwala Health Centre

    Lusaka

  • University Teaching Hospital

    Lusaka

Other trials in Zambia

About this study

Official title: Preventing Preterm Birth in Zambia

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.

Read the detailed description

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).

Throughout 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

During 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. .

At 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.

There 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.

Maternal 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

Keywords
Pregnancy, Stillbirth, Preterm birth
Medical subject headings
Stillbirth, Premature Birth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preterm Birth <37

    Proportion of deliveries occurring prior to 37 weeks gestation

    Measured: Measured at delivery

Secondary outcomes (15)

  1. Preterm Birth <34

    Proportion of deliveries occurring prior to 34 weeks gestation

    Measured: Measured at delivery

  2. Preterm Birth <28

    Proportion of deliveries occurring prior to 28 weeks gestation

    Measured: Measured at delivery

  3. Low Birth Weight

    Proportion of newborns weighing less than 2500 grams at delivery

    Measured: Measured at delivery

  4. Very Low Birth Weight

    Proportion of newborns weighing less than 1500 grams at delivery

    Measured: Measured at delivery

  5. Preterm prelabor rupture of membranes (PPROM)

    Proportion of women with PPROM

    Measured: Enrollment through delivery

  6. Spontaneous delivery prior to 37 weeks of gestation

    Proportion of spontaneous deliveries

    Measured: Enrollment through 37 weeks gestation

  7. Spontaneous delivery prior to 34 weeks of gestation

    Proportion of spontaneous deliveries

    Measured: Enrollment through 34 weeks gestation

  8. Spontaneous delivery prior to 28 weeks of gestation

    Proportion of spontaneous deliveries

    Measured: Enrollment through 28 weeks gestation

  9. Birth weight <10th percentile for gestational age

    Proportion of newborns with birth weight < 10th percentile for gestational age

    Measured: Measured at delivery

  10. Birth weight <3rd percentile for gestational age

    Proportion of newborns with birth weight <3rd percentile for gestational age

    Measured: Measured at delivery

  11. Mother-to-child HIV transmission by 6 weeks postpartum

    Proportion of HIV positive newborns

    Measured: Delivery through 6 weeks postpartum

  12. Mother-to-child HIV transmission by 12 months postpartum

    Proportion of HIV positive infants

    Measured: Delivery through 12 months postpartum

  13. Maternal mortality

    Death of a maternal participant for any reason

    Measured: Enrollment through 12 months postpartum

  14. Fetal, neonatal, and infant mortality

    Death of a fetal, neonatal, or infant participant for any reason

    Measured: Enrollment through 12 months postpartum

  15. Infant APGAR scores

    APGAR scores at delivery

    Measured: Measured at delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study startAug 2015
  3. Primary completion5 Oct 2025
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
9,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738892
Sponsor's protocol ID
14-2113
Acronym
ZAPPS
Status last verified
Feb 2026
First submitted
6 Apr 2016
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22692417

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

    PubMed 22866189

  • 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.

    PubMed 15286219

  • 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.

    PubMed 22682464

  • 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.

  • 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.

    PubMed 18177778

  • 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.

    PubMed 24219711

  • 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.

    PubMed 19951079

  • 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.

    PubMed 15752534

  • 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.

    PubMed 24428470

  • 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.

    PubMed 20147718

  • 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.

    PubMed 20348884

  • 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.

    PubMed 22344727

  • 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.

    PubMed 17206962

  • 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.

    PubMed 17206980

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Stillbirth, run by University of North Carolina, Chapel Hill at 2 sites in Zambia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preterm Birth <37 (time frame: Measured at delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738892, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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