Sexually transmitted infections Pregnancy and Childbirth Urological and Genital Diseases
Conditions
Interventions
Aetiological management
Syndromic management
Sponsors
London School of Hygiene and Tropical Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria will be pregnant women, 1. Maximum gestational age of 23 weeks and 6 days (i.e. < 24 weeks) assessed through an ultrasound scan 2. Intending to be based in Harare for pregnancy, delivery, and neonatal period 3. Agreeing to have vaginal swabs collected for STI testing
Exclusion criteria
Exclusion criteria: 1. Any condition that may prove fatal to the mother during the study period (e.g. malignancy, end-stage HIV disease or other conditions deemed likely fatal by the trial obstetrician or paediatrician) 2. Condition likely to lead to lack of understanding of study procedures or to uncooperative behaviour (e.g. neurocognitive disease, developmental delay or psychiatric illness) 3. Unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary trial outcome is a composite of the proportion of babies among total births (live and dead): born premature (before 37 completed weeks gestation, based on obstetric ultrasound scan conducted within 24 weeks’ gestation); and/or low birthweight (500g without sign of life). In the event of multiple births, considering the primary outcome is a hybrid of maternal (prematurity) and child-level (low birthweight and stillbirth) outcomes, the primary outcome will be measured at the maternal level (i.e., if either child of the multiple births experience any of the composite outcomes it will be recorded as having the adverse outcome). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are each individual outcome of the composite primary outcome (i.e., babies who are premature, babies who are stillborn, babies who are low birthweight), and proportions of: women who have curable STIs diagnosed and treated in pregnancy; women with prelabour rupture of membranes (PROM; stratified by pre-term or term), babies that are small for gestational age, early and late neonatal deaths (<7 and <28 days respectively; as a proportion of live births), newborns with conjunctivitis, pneumonia or sepsis within the first six weeks of life. All outcomes are measured as a proportion of total births except for neonatal death which is measured as a proportion of live births. | — |
Countries
Zimbabwe
Contacts
Public ContactJacqueline Kabongo
Trial Manager
Outcome results
None listed