Zambian Preterm Birth Prevention Study

Summary

Participation Requirements

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 ...

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, and also at the time of discharge from the hospital after delivery if possible. During antenatal 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. An additional fetal biometry ultrasound will be performed at 32 weeks. At 24 and 28 weeks, blood, urine, and vaginal swabs will be collected. HIV testing will be repeated at 28 weeks. 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). Information on interval complications and mortality at the time that the mother and/or her infant(s) are discharged from hospital will also be obtained. There will be one study visit during the postnatal period, at 42-days post-partum. At this visit, routinely recommended screening and treatment will be provided. Participants will be screened for depression using the EPDS.

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