Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
- Conditions
- Premature Birth
- Interventions
- Behavioral: Antenatal Care
- Registration Number
- NCT03673709
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
In this study, we test the effectiveness of an evidence-based model of group antenatal care by comparing it to individual (usual) antenatal care. We simultaneously identify the degree of implementation success and the contextual factors associated with success across 6 antenatal clinics in Blantyre District, Malawi. If results are negative, governments will avoid spending on ineffective care. Positive maternal, neonatal and HIV-related outcomes of group antenatal care will save lives, impact the cost and quality of antenatal care, and influence health policy as governments adopt this innovative model of care nationally.
- Detailed Description
Sub-Saharan Africa has the world's highest rates of maternal and perinatal mortality and accounts for 2/3 of new HIV infections and 1/4 of preterm births. Antenatal (prenatal) care is the entry point into the health system for many women and offers a unique opportunity to provide life-saving monitoring. However, provider shortages, low quality of care and failure to attend all recommended visits mean that the potential benefits of antenatal care are not realized. There is an urgent need to test novel interventions to reduce health risks for mother and child. Group antenatal care is a transformative model of care that provides a positive pregnancy experience, uses provider time efficiently, and improves perinatal and HIV-related outcomes. Women in group antenatal care have 2-hour visits with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women conduct self-assessments, briefly consult the midwife, and meet for 80-90 minutes of interactive health promotion enlivened by games and role-plays. Women form relationships with midwives and each other. In a US randomized clinical trial (RCT), group care improved prematurity rates, antenatal care attendance, satisfaction with care, breastfeeding practices, safer sex behaviors, and uptake of family planning. Our randomized pilot in Malawi and Tanzania had promising outcomes. More women in group care than in usual care completed ≥4 antenatal visits (94% vs 58%). Their partners were more likely to be tested for HIV during pregnancy (51% vs. 27%). We established that group antenatal care can be offered in a rigorous RCT with high fidelity despite provider shortages. The next step is an adequately powered effectiveness trial. Malawi is an especially appropriate site because it has the world's highest prematurity rate (18%) and high HIV prevalence (10% nationally, 16% at the study site). We use a hybrid design to simultaneously conduct an effectiveness RCT with individual-level randomization and examine implementation processes at 6 clinics in Blantyre District, Malawi. Aim 1 is to evaluate the effectiveness of group antenatal care through 6 months postpartum. We hypothesize that compared to usual care, women in group care and their infants will have less morbidity and mortality and more positive HIV prevention outcomes. We test Aim 1 hypotheses using multi-level hierarchical models using data from repeated surveys and health records. Aim 2 is to identify clinic-level degree of implementation success and contextual factors associated with success for each clinic and across clinics. Analyses use within and across-case matrices. This high-impact study addresses three global health priorities, maternal and infant mortality and HIV prevention, that affect all women of childbearing age in Malawi. The Ministry of Health strongly supports this project; results will help them decide whether to scale-up this innovative model of group care. Negative results will avoid spending on ineffective care. Positive results will provide evidence needed to adopt group antenatal care nationally and in other low-resource countries.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1887
- Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)
- Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Antenatal Care (intervention) Antenatal Care Women have the same number of visits as those in individual care. Their first antenatal care (intake) and first postnatal visit is done individually (identical to individual care). Women in group care bypass the waiting area and have a 2-hour visit with the same provider in a group of 8-12 women at a similar stage of pregnancy. Women assess their blood pressure and weight, briefly consult the midwife in a corner of the room, and meet for 80-90 minutes of interactive health promotion, enlivened by games and role-plays.
- Primary Outcome Measures
Name Time Method Preterm birth 8 weeks postpartum Newborn born early
Partner HIV Test Enrollment, 36-42 weeks gestation Proportion of partners tested during this pregnancy
- Secondary Outcome Measures
Name Time Method Low birthweight 8 weeks postpartum Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth
Stillbirth 8 weeks postpartum Baby born with no signs of life at or after 28 weeks gestational age
Maternal death 8 weeks postpartum, 6 months postpartum Woman dies in pregnancy or within 42 days of the end of pregnancy
Woman HIV test Enrollment, 36-42 weeks gestation Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy
Anemia Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum Hemoglobin
Family planning 8 weeks postpartum; 6 months postpartum Using a family planning method (yes/no)
ART medication (woman) Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum Received medication from intake through six months postpartum
Healthcare utilization 36-42 weeks gestation; 8 weeks postpartum Pre- and postnatal care attendance; health facility birth (yes/no), services received (21 items); content covered (18 items)
Self Reporting Questionnaire (SRQ) Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum The Self Reporting Questionnaire (SRQ) is a brief measure of psychiatric symptomatology designed by the WHO to be used to screen for common mental disorders. It consists of 20 questions with yes/no answers exploring symptoms of depression, anxiety, and somatic complaints such as headache and non-specific gastrointestinal symptoms. SRQ has been translated and validated in several African countries. A recent study conducted in Rwanda reported the α = 0.85 for refugee women. It consists of 20 Yes/No Items, with a total score range from 0-20; α = 0.789. Higher scores indicate more distress.
Neonatal death 8 weeks postpartum Newborn dies between 0-28 days after birth
Spontaneous abortion 36-42 weeks gestation Pregnancy loss less than 20 weeks
Exclusive breastfeeding 8 weeks postpartum; 6 months postpartum Duration in days
Early repeat pregnancy 8 weeks postpartum; 6 months postpartum Negative pregnancy test and no reported pregnancy loss
HIV test infant Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum Infant tested for HIV and results received
Adequate HIV knowledge Enrollment, 36-42 weeks gestation Total HIV Knowledge is the number of questions answered correctly for five HIV-prevention items defined by UNAIDS as essential plus an additional four items from the Malawi Demographic and Health Survey assessing prevention of maternal-to-child transmission. Higher scores indicate more knowledge about how HIV is transmitted.
Satisfaction with care 36-42 weeks gestation 10-item satisfaction with antenatal care index; 5 point Likert scale \[1 (poor) and to 5 (excellent)\], range 10-50, α =0.980
Trial Locations
- Locations (6)
Chileka HC
🇲🇼Blantyre, Malawi
Lirangwe HC
🇲🇼Blantyre, Malawi
Madziabango HC
🇲🇼Blantyre, Malawi
Bangwe HC
🇲🇼Blantyre, Malawi
Chilomoni HC
🇲🇼Blantyre, Malawi
Limbe HC
🇲🇼Blantyre, Malawi