Rupture of Membranes; Premature

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.

This study is a non-blinded, prospective, randomized controlled trial designed to compare the effect of outpatient oral antibiotics (i.e., amoxicillin and azithromycin) on the length of time (days) that pregnancy continues after a patient's water bag has ruptured prematurely. If a patient has been diagnosed with rupture of their water bag between 18 0/7 weeks and 22 6/7 weeks and there are no other associated complications with the pregnancy, the patient is eligible for initial consideration for this study. Patients will be admitted to the hospital for a 24-hour monitoring period. If the patient remains without further complications during this monitoring period, the patient will be eligible for enrollment. If enrollment is desired, the patient will be randomly assigned to receive either antibiotics (treatment arm of the study) or no antibiotics (control arm of the study). The treatment arm will receive an outpatient, 7-day course of oral antibiotics (azithromycin and amoxicillin) with the first dose given in the hospital to ensure no side effects. The control arm will not receive outpatient antibiotics. Both groups will have weekly, office follow-up visits with high-risk pregnancy specialists to ensure no further complications. Both groups will be admitted to the hospital if the patients reach 23 0/7 weeks without complications. At this time the patients will receive all medications and therapies recommended by the governing board of OBGYNs. Subjects of both groups will also be admitted before 23 0/7 weeks if further complications noted either at their clinic follow up visits or anytime outside of the hospital. The duration of time that the patient remains pregnant after breaking of the water bag will be compared in each group. The investigators will also see if there is a difference in the number of patients able to reach 23 0/7 weeks between each group (treatment versus control).