Primary Outcome Measures:
- Proportion of preterm births [ Time Frame: once, after delivery ] [ Designated as safety issue: No ]
- Number of serious and any adverse events [ Time Frame: Cumulative during pregnancy and neonatal period ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percentage of low birth weight babies [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
- Mean birth weight [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
- Mean duration of gestation [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
- Percentage of low chest circumference at birth [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
- Percentage of low chest or head circumference at birth [ Time Frame: Once, after delivery ] [ Designated as safety issue: No ]
- Incidence of moderate underweight during infancy [ Time Frame: Cumulative during infancy ] [ Designated as safety issue: No ]
- Perinatal, neonatal and infant mortality [ Time Frame: Cumulative during infancy ] [ Designated as safety issue: No ]
- Mean maternal blood haemoglobin concentration at each antenatal visit and at 1, 3, and 6 months after delivery [ Time Frame: Several antenatal and postnatal visits ] [ Designated as safety issue: No ]
- Percentage of women with mild, moderate or severe anaemia at every antenatal visit and at 1, 3, and 6 months after delivery [ Time Frame: Several antenatal and postnatal visits ] [ Designated as safety issue: No ]
- Percentage of women with peripheral blood malaria parasitaemia and mean parasite density at enrolment, at 32 gestational weeks and at delivery [ Time Frame: at enrolment, at 32 weeks, and at delivery ] [ Designated as safety issue: No ]
- Percentage of women with cord blood and placental malaria parasitaemia at delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]
- Maternal weight gain during pregnancy [ Time Frame: Once after pregancy ] [ Designated as safety issue: No ]
- Mean number of maternal illness days during pregnancy [ Time Frame: Cumulative during pregnancy ] [ Designated as safety issue: No ]
- Prevalence of maternal chlamydia trachomatis, neisseria gonorrhoea, and vaginal trichomoniasis infection at 4 weeks after delivery [ Time Frame: At 4 weeks after delivery ] [ Designated as safety issue: No ]
Maternal anaemia, preterm deliveries and low birth weight are common in Sub-Saharan Africa and contribute significantly to the ill-health of pregnant women and infants. The present study is based on the assumption that these adverse outcomes can be prevented by improved antimicrobial management of malaria and sexually transmitted infections (STI) among pregnant women. To test the hypothesis, a randomised clinical trial following Good Clinical Practice (GCP) is being carried out in Malawi, South-Eastern Africa.
A total of 1320 consenting women who present at a rural antenatal clinic after 14 but before 26 completed gestation weeks will be enrolled. One third of the women will receive antenatal care according to national recommendations, including regular visits to health centre, screening for pregnancy complications, haematinic and vitamin A supplementation and two doses of presumptive malaria treatment with sulfadoxine-pyrimethamine. Another third will receive otherwise the same care, but sulfadoxine-pyrimethamine treatment is given at monthly intervals. The final third receives standard antenatal care, sulfadoxine-pyrimethamine treatment at monthly intervals and two doses of presumptive STI treatment with azithromycin. Women are monitored throughout pregnancy and delivery and newborn growth will be followed up for five years.
The primary outcome measure is proportion of preterm births in the three study groups. Secondary maternal outcomes include anaemia and malaria parasitaemia during pregnancy, at delivery and at 1, 3, and 6 months after delivery, gestational weight gain and morbidity and STI prevalence after delivery. Secondary child outcomes consist of proportion of babies with low birth weight, mean birth weight, growth in infancy and childhood, incidence of malnutrition in infancy and childhood, and mortality. Additionally, information is collected on the development of malaria-specific humoral immunity in pregnancy and participant experiences from the study. Participant safety is systematically monitored throughout the intervention.