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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
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
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
Sponsors and contacts
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