The enhanced antenatal care bundle to improve maternal and newborn outcomes in pregnant women attending maternity health services in Malawi: a multi-country, parallel cluster-randomised trial
Delivery of antenatal care services
The study will implement a package designed to improve the quality and content of antenatal care delivered in resource-limited settings and compare this with the standard antenatal care offered to pregnant women in Malawi. This is a multi-country, parallel cluster-randomised controlled trial with a baseline period. There is an integrated implementation evaluation and health economic evaluation. The trial will include primary healthcare centres in Malawi as clusters. During the first 3 months each cluster will provide standard care to establish weekly rates of maternal and newborn outcomes. After the baseline, the clusters will be randomly allocated in a 1:1 ratio to ENHANCE or standard care with the provision of basic ANC supplies, using a minimisation algorithm to account for the imbalance in location, hospital deliveries volume and distance to referral facility. Both quantitative and qualitative approaches will gather the data required to meet the objectives. The researchers will conduct an intention-to-treat analysis of the composite primary outcome. Descriptive statistics for continuous (mean and standard deviations), discrete (median and range or interquartile range) and categorical (frequency counts and percentages) variables will summarize baseline characteristics (demographic and clinical data) and outcome variables. Process evaluation surveys will be summarised using descriptive statistics as appropriate, and responses compared across PHCs and countries. Interviews will be analysed using combined deductive framework and inductive thematic analysis.
Clusters: Primary Health Centre facilities offering maternity care will be included as a cluster following the completion of a successful feasibility report with the minimum prerequisites of: 1. A minimum of 700 ANC initial visits to a maximum of 2000 per year 2. Providers of basic emergency obstetric care 3. Public primary facility 4. Completed the site readiness assessment process Participants: clients (in process evaluation interviews and survey): 1. ≤ 20 weeks of gestation at the initial visit to ANC 2. Able to provide informed consent 3. Willing to participate in the study 4. Aged 18 years and above Participants: HCWs (in process evaluation interviews and survey): 1. Healthcare workers responsible for the care of women during pregnancy 2. Willing to participate in the study 3. Able to provide informed consent
Clusters: 1. PHC with less than 700 initial ANC visits per year 2. PHCs with more than 2000 initial ANC visits per year-outliers to other facilities 3. PHCs not willing to participate in the study 4. High risk of contamination (geographically close to another participating centre or site where similar interventions are already taking place) Participants: clients (in process evaluation - interviews and survey): 1. >20 weeks of gestation at the initial visit to ANC 2. Unable to provide informed consent 3. Medical and obstetric complications on the initial visit 4. Aged less than 18 years Participants: HCWs (in process evaluation - interviews and survey): 1. Not willing to participate in process evaluation 2. Unable to provide informed consent