Premature Birth
Conditions
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 (Aim 1) across 7 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 conducted an effectiveness RCT with individual-level randomization. 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. 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.
Interventions
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.
Sponsors
Study design
Masking description
The research team working on the effectiveness evaluation of group care is blinded to study condition and is charged with collecting the Aim 1 effectiveness data from the individuals.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Born Weighing Less Than 2500 g | 8 weeks postpartum | Whether a newborn weighed \<2,500 grams at birth (yes/no) is used as a proxy for preterm birth due to the lack of accurate gestational age data. |
| Partner HIV Test | 36-42 weeks gestation | Proportion of partners tested during this pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Abortion | 36-42 weeks gestation | Pregnancy loss less than 20 weeks |
| Stillbirth | 8 weeks postpartum | Baby born with no signs of life at or after 28 weeks gestational age |
| Infant Death | 6 months postpartum | Infant death before the end of the study |
| Maternal Death | 6 months postpartum | Maternal death before the end of the study |
| Anemia | 36-42 weeks gestation | Hemoglobin level of \<11 g/dl |
| Family Planning | 6 months postpartum | Reported use of family planning at late postpartum, approximately 6 months after delivery |
| Exclusive Breastfeeding | 6 months postpartum | Exclusive breastfeeding for six months (yes) |
| Self Reporting Questionnaire (SRQ) | 8 weeks postpartum | Self-Reporting Questionnaire has 20 yes/no items that screen for symptoms of anxiety, depression, psychosomatic symptoms, reduced vital energy, and depressive thoughts. Score range is a minimum of 0 and a maximum of 20 for a total score; a higher score indicates higher distress. |
| Satisfaction With Antenatal Care (ANC) | 36-42 weeks gestation | A 10-item scale rating satisfaction with the overall quality of the care, the procedures, providers' level of respect and listening skills, with response options of a 5-point Likert scale ("1= Poor; 2= Fair; 3= Good; 4= Very good; 5= Excellent). The range is 10-50, with higher scores indicating greater satisfaction with care. |
| Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct | 36-42 weeks gestation | Joint United Nations Programme on HIV/AIDS (UNAIDS) comprehensive HIV prevention knowledge measured as whether the person answered all five questions correctly: if a healthy-looking person can have HIV, whether condom use and having only one uninfected partner reduce the likelihood of getting HIV transmission and two of the most common local misconceptions about HIV transmission (casual contact and mosquito bites). |
| Mean Antenatal Care (ANC) Contacts | 8 weeks postpartum | Mean number of antenatal care (ANC) contacts. Minimum is 1 since all participants were recruited at their first contact, and maximum is unlimited, but 8 was the ecommended number of contacts |
| Pregnancy-related Empowerment Scale (PRES) | 36 to 42 weeks gestation | The 16-item Likert-type scale with 1 (strongly disagree) to 4 (strongly agree) capturing a sense of control over pregnancy health and healthcare across four domains: provider connectedness, skillful decision-making, peer connectedness, and gaining voice; range 16-64 with a higher score indicating feeling more empowerment. |
| Wait Time | 36-42 weeks gestation | Waited less than one hour for antenatal care (ANC) services (% yes) |
| Prefer Group Antenatal Care (ANC) in the Future | 36-42 weeks gestation | In late pregnancy, participants were asked if they would prefer individual or group antenatal care (ANC) if pregnant in the future (% preferring group ANC). |
Countries
Malawi
Contacts
University of Illinois at Chicago
Participant flow
Recruitment details
Data were collected between 5 July 2019 and 10 August 2023, comparing outcomes for pregnant women randomly assigned to Group ANC or Individual ANC at seven clinics in Blantyre District, Malawi. The sample size was 1887 for the detection of a reduced preterm birth rate from 18% in the individual care arm to 12% in the Group ANC arm, controlling for 80% statistical power and 30% retention
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 15-19 years | 496 Participants |
| Age, Customized 20-29 years | 1115 Participants |
| Age, Customized 30-35 years | 276 Participants |
| Education category Completed primary | 767 Participants |
| Education category Less than primary | 414 Participants |
| Education category More than primary | 133 Participants |
| Experienced Food Insecurity in last 12 months No, Did Not Experience Food Insecurity in last 12 months | 292 Participants |
| Experienced Food Insecurity in last 12 months Yes, Did Experience Food Insecurity in last 12 months | 649 Participants |
| In a relationship (married, living with a partner, or dating) In a relationship (married, living with a partner, or dating) | 886 Participants |
| In a relationship (married, living with a partner, or dating) Not In a relationship (married, living with a partner, or dating) | 127 Participants |
| Ownership Index (0-3) 0 items owned | 370 Participants |
| Ownership Index (0-3) 1 item owned | 454 Participants |
| Ownership Index (0-3) 2 items owned | 271 Participants |
| Ownership Index (0-3) 3 items owned | 41 Participants |
| Ownership Index (0-3) Missing | 0 Participants |
| Pregnant for the first time (\primiparous) | 774 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 941 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Malawi | 941 participants |
| Sex: Female, Male Female | 941 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 941 | 16 / 815 | 1 / 946 | 22 / 848 |
| other Total, other adverse events | 0 / 941 | 0 / 815 | 0 / 946 | 0 / 848 |
| serious Total, serious adverse events | 0 / 941 | 0 / 815 | 0 / 946 | 0 / 848 |