This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and whether this approach is affordable and cost-effective for the health system.
About 2,000 pregnant women attending their first antenatal care visit at up to 10 government clinics in Botswana will be invited to join the study. All women will first receive the usual antenatal care services provided in Botswana, including routine health checks and HIV and syphilis testing. Women who enroll in the study will be randomly assigned to one of two groups:
1. Standard of care group: Women receive routine antenatal care only. 2. Intervention group: In addition to routine antenatal care, women are screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester.
The main outcome of the study is whether screening and treating chlamydia and gonorrhoeae reduces preterm birth (before 37 weeks). Other outcomes include low birth weight, very preterm birth, and maternal health conditions.
Asymptomatic for cervicovaginitis at first ANC (i.e., not syndromically treated for an STI by clinic midwives at first ANC)
Age ≥ 15 years
Currently pregnant
≤20 weeks gestation (based on gestational age in obstetric record or last menstrual period if gestational age missing from record)
None
Parallel
Chlamydia trachomatis and Neisseria gonorrhoeae screening
Diagnostic testScreening with Xpert® CT/NG assay at first antenatal care and third trimester
Preterm birth
\<37 weeks gestation
Infant Outcomes: low birth weight, and a composite measure of preterm or low birth weight; very preterm birth; and preterm birth sub-types.
Low birth weight: \<2500g Very preterm birth: \<32 weeks gestation Preterm birth sub-types: spontaneous, medically indicated
Pregnancy/maternal outcomes: gestational hypertension, preeclampsia, incident HIV infection.
Gestational hypertension: one-two elevations of systolic 140+ or diastolic blood pressure 90+ after 20 weeks pregnancy Preeclampsia: hypertension with substantial proteinuria after 20 weeks pregnancy
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Adriane Wynn
Lead sponsor
University of California, San Diego
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Botswana Harvard AIDS Institute Partnership
Collaborator