Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMakerere University

About this trial

Pregnancy complications such as pre-eclampsia (high blood pressure during pregnancy), poor fetal growth, unexplained stillbirth, and spontaneous preterm birth are major causes of illness and death for mothers and babies in sub-Saharan Africa. These conditions, known as the Great Obstetrical Syndromes, are thought to result from problems with the development of the placenta early in pregnancy. However, there is limited information from African populations to help identify women at risk or improve prevention and treatment.

This study will enroll 4,000 first-time pregnant women in Uganda before 18 weeks of pregnancy and follow them throughout pregnancy until delivery. Participants will attend routine study visits where information about their health, pregnancy, and social circumstances will be collected. Physical examinations, ultrasound scans, and blood samples will be obtained at several time points during pregnancy, and blood and placental samples will be collected at birth. Some samples will be analyzed during the study, while others will be stored for future research with appropriate ethical approval.

The study will examine which clinical, biological, and social factors are associated with pregnancy complications. Researchers will use statistical methods and artificial intelligence (AI) techniques to identify patterns that may help predict which women are at increased risk of developing these conditions.

The knowledge gained from this study may support the development of better screening tools and strategies for preventing pregnancy complications, improve maternal and newborn health outcomes in Uganda and other African settings, and establish a valuable biobank to support future maternal and newborn health research.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Viable singleton pregnancy at the time of the dating ultrasound scan

At less than 18 weeks of gestation by ultrasound scan

Nulliparous

Women who are indigenous Africans

Disqualifiers

None

Trial population

Participants will be nulliparous pregnant women attending antenatal clinics at Kawempe and Mulago Hospitals, Uganda.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 1 trial group
Group A: Nulliparous pregnant women attending antenatal clinic

Trial outcomes

Primary outcomes

1

Number of Participants who Develop Pre-eclampsia

Pre-eclampsia will be defined as new-onset hypertension at 20 weeks of gestation or later, characterized by a systolic BP of ≥140 mmHg and/or diastolic BP of ≥90 mmHg on at least two occasions at least 4 hours apart, with proteinuria of ≥+1 on urine dipstick on at least one occasion.

Time frame
From recruitment until the date of first documented hypertension plus proteinuria or date of delivery whichever came first
2

Number of Participants who Experience Spontaneous Preterm Birth

Spontaneous preterm birth will be defined as delivery occurring after fetal viability (≥28 weeks of gestation) but before 37 completed weeks of gestation, following spontaneous onset of labor or spontaneous preterm prelabor rupture of membranes. Spontaneous preterm birth will exclude preterm deliveries initiated by medical intervention for maternal or fetal indications.

Time frame
From recruitment to date of delivery before 37 completed weeks of gestation
3

Number of Participants who Develop Fetal Growth Restriction

Fetal growth restriction will be defined as a birth weight below the 10th percentile for gestational age

Time frame
From recruitment to date of delivery
4

Number of Participants who give birth to a stillbirth.

Stillbirth will be defined as the death of a fetus occurring before or during delivery after the threshold of viability (≥28 weeks of gestation in this study). This includes both antepartum and intrapartum stillbirth

Time frame
From recruitment to date of delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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