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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03673709
Other study ID # 2018-0845
Secondary ID R01NR018115
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 5, 2019
Est. completion date May 31, 2024

Study information

Verified date April 2024
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 1776
Est. completion date May 31, 2024
Est. primary completion date August 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years and older
Eligibility Inclusion Criteria: - Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language) Exclusion Criteria: - Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Antenatal Care
Women in group care bypass the waiting room and have a 2-hour visit with the same provider with a group of 8-12 women at a similar stage of pregnancy. Women assess their own 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.

Locations

Country Name City State
Malawi Bangwe HC Blantyre
Malawi Chileka HC Blantyre
Malawi Chilomoni HC Blantyre
Malawi Limbe HC Blantyre
Malawi Lirangwe HC Blantyre
Malawi Madziabango HC Blantyre

Sponsors (3)

Lead Sponsor Collaborator
University of Illinois at Chicago National Institute of Nursing Research (NINR), University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preterm birth Newborn born early 8 weeks postpartum
Primary Partner HIV Test Proportion of partners tested during this pregnancy Enrollment, 36-42 weeks gestation
Secondary Spontaneous abortion Pregnancy loss less than 20 weeks 36-42 weeks gestation
Secondary Stillbirth Baby born with no signs of life at or after 28 weeks gestational age 8 weeks postpartum
Secondary Low birthweight Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth 8 weeks postpartum
Secondary Neonatal death Newborn dies between 0-28 days after birth 8 weeks postpartum
Secondary Maternal death Woman dies in pregnancy or within 42 days of the end of pregnancy 8 weeks postpartum, 6 months postpartum
Secondary Woman HIV test Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy Enrollment, 36-42 weeks gestation
Secondary Anemia Hemoglobin Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary Family planning Using a family planning method (yes/no) 8 weeks postpartum; 6 months postpartum
Secondary Exclusive breastfeeding Duration in days 8 weeks postpartum; 6 months postpartum
Secondary Early repeat pregnancy Negative pregnancy test and no reported pregnancy loss 8 weeks postpartum; 6 months postpartum
Secondary ART medication (woman) Received medication from intake through six months postpartum Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary HIV test infant Infant tested for HIV and results received Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary Self Reporting Questionnaire (SRQ) 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 a = 0.85 for refugee women. It consists of 20 Yes/No Items, with a total score range from 0-20; a = 0.789. Higher scores indicate more distress. Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Secondary Satisfaction with care 10-item satisfaction with antenatal care index; 5 point Likert scale [1 (poor) and to 5 (excellent)], range 10-50, a =0.980 36-42 weeks gestation
Secondary Healthcare utilization Pre- and postnatal care attendance; health facility birth (yes/no), services received (21 items); content covered (18 items) 36-42 weeks gestation; 8 weeks postpartum
Secondary Adequate HIV knowledge 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. Enrollment, 36-42 weeks gestation
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