Effect of an integrated community-based intervention on antenatal care, incidence of malaria in pregnancy, adverse pregnancy and birth outcomes in rural Mali and Burkina Faso: The INTEGRATION cluster randomized trial

Abstract Background The WHO recommends at least eight antenatal care (ANC) contacts per pregnancy to improve maternal and child health. However, ANC coverage remains low in many settings in sub-Saharan Africa. Preventive measures, including intermittent preventive treatment of malaria with sulfadoxine-pyrimethamine during pregnancy (IPTp-SP), are crucial for reducing adverse pregnancy outcomes. This study assessed the effect of a community-based intervention on maternal and child health outcomes and malaria incidence in pregnancy in rural Mali and Burkina Faso. Methods This is a secondary analysis based on data from the INTEGRATION randomized cluster trial, encompassing 40 trial clusters (20 in Mali and 20 in Burkina Faso). The INTEGRATION intervention consisted of delivering IPTp-SP to pregnant women during seasonal malaria chemoprevention home visits from July to October over two consecutive years (2022 and 2023). Outside this four-month period, as in the control arm, IPTp-SP was given at the maternity clinic. Data were collected from the 40 study health facilities between January 2020 and June 2022 (pre-intervention period) and July 2022 and April 2024 (post-intervention period). The primary outcomes were ANC4+ coverage, cumulative incidence of malaria in pregnancy, and adverse pregnancy and birth outcomes, defined as any of the following: prematurity, low birth weight, stillbirth, or maternal death. A difference-in-differences model assessed the intervention’s effect on outcomes at the cluster level. Statistical significance was set at a 0.05 level. Results A total of 11,199 women in Burkina Faso and 35,351 women in Mali delivered during the study period. After adjusting for age and parity, the intervention did not show any statistically significant effect on ANC4+ coverage (Burkina Faso: -2.598; 95% CI [-13.400 – 8.202], Mali: -2.72; 95% CI [-14.35 – 8.91]), adverse pregnancy and birth outcomes (Burkina Faso: -0.194; 95% CI [-4.375 – 6.593], Mali: -0.36; 95% CI [-8.61 – 7.89]), or cumulative incidence of malaria in pregnancy (Burkina Faso: 125.56; 95% CI [-389 – 640], Mali: -12.68; 95% CI [-221 – 196]). Conclusion In both Burkina Faso and Mali, the four-month community-based intervention did not yield any statistically significant effect on maternal or pregnancy outcomes. Extending the duration of such interventions may be necessary to achieve meaningful reductions in the targeted outcomes. Trial registration Retrospectively registered on August 11th, 2022; registration # PACTR202208844472053 (Pan African Clinical Trials Registry: https://pactr.samrc.ac.za/Search.aspx ). Protocol v4.0 dated September 04, 2023. Trail sponsor: University of Sciences Techniques and Technologies of Bamako (USTTB), Mali.