Zambian Preterm Birth Prevention Study

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT02738892
• Date of registration: 06/04/2016
• Prospective Registration: No
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Zambian Preterm Birth Prevention Study ZAPPS
• Scientific title: Preventing Preterm Birth in Zambia
• Date of first enrolment: August 2015
• Target sample size: 9000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02738892
• Study type: Observational

Countries of recruitment

Zambia

Contacts

• Name: Jeff Stringer, MD
• Affiliation: University of North Carolina, Chapel Hill

• Name: Joan Price, MD, MPH

Key inclusion & exclusion criteria

Inclusion Criteria:

Pregnant women =15 years will be eligible to participate. Additionally, participants will:

1. Have a completed screening ultrasound with gestational age < 20 weeks

2. Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 [3 Nov 2017]
enrolled both HIV-infected and uninfected women)

3. Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound

4. Reside within Lusaka with no plans to relocate during the study follow-up period

5. Be willing to provide written, informed consent

6. Be willing to allow their infants to participate in the study

Exclusion criteria:

1. Pregnant women > 24 weeks' gestation or with screening ultrasound = 16 weeks

2. Infants born to women not enrolled in the study



Age minimum: 15 Years
Age maximum: 49 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

Stillbirth

Preterm Birth

Primary Outcome(s)

Preterm Birth <37 [Time Frame: Measured at delivery]

Secondary Outcome(s)

Low Birth Weight [Time Frame: Measured at delivery]

Preterm prelabor rupture of membranes (PPROM) [Time Frame: Enrollment through delivery]

Spontaneous delivery prior to 37 weeks of gestation [Time Frame: Enrollment through 37 weeks gestation]

Mother-to-child HIV transmission by 12 months postpartum [Time Frame: Delivery through 12 months postpartum]

Mother-to-child HIV transmission by 6 weeks postpartum [Time Frame: Delivery through 6 weeks postpartum]

Fetal, neonatal, and infant mortality [Time Frame: Enrollment through 12 months postpartum]

Infant APGAR scores [Time Frame: Measured at delivery]

Spontaneous delivery prior to 34 weeks of gestation [Time Frame: Enrollment through 34 weeks gestation]

Very Low Birth Weight [Time Frame: Measured at delivery]

Preterm Birth <28 [Time Frame: Measured at delivery]

Birth weight <10th percentile for gestational age [Time Frame: Measured at delivery]

Birth weight <3rd percentile for gestational age [Time Frame: Measured at delivery]

Maternal mortality [Time Frame: Enrollment through 12 months postpartum]

Preterm Birth <34 [Time Frame: Measured at delivery]

Spontaneous delivery prior to 28 weeks of gestation [Time Frame: Enrollment through 28 weeks gestation]

Secondary ID(s)

14-2113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation

Global Alliance to Prevent Prematurity and Stillbirth