search
Back to results

Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi

Primary Purpose

Premature Birth

Status
Active
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Antenatal Care
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Premature Birth

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Bangwe HC
  • Chileka HC
  • Chilomoni HC
  • Limbe HC
  • Lirangwe HC
  • Madziabango HC

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Individual Antenatal Care (usual care)

Group Antenatal Care (intervention)

Arm Description

Women are provided antenatal care services on a first come, first serve basis and listen to a health lecture. They meet individually with a midwife for a physical assessment. Women complete laboratory tests (including HIV testing) at their first visit. Congruent with the new WHO recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.

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.

Outcomes

Primary Outcome Measures

Preterm birth
Newborn born before 37 weeks gestational age
Partner HIV Test
Proportion of partners tested during this pregnancy

Secondary Outcome Measures

Spontaneous abortion
Pregnancy loss less than 20 weeks
Stillbirth
Baby born with no signs of life at or after 28 weeks gestational age
Low birthweight
Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth
Neonatal death
Newborn dies between 0-28 days after birth
Maternal death
Woman dies in pregnancy or within 42 days of the end of pregnancy
Woman HIV test
Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy
Anemia
Hemoglobin
Postpartum bleeding
Blood loss of greater than 500 ml (yes/no) or greater than 1000 ml (yes/no)
Hypertension
Blood pressure
Family planning
Using a family planning method (yes/no)
Exclusive breastfeeding
Duration in days
Early repeat pregnancy
Negative pregnancy test and no reported pregnancy loss
ART medication (woman)
Received medication from intake through six months postpartum
HIV test infant
Infant tested for HIV and results received
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 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.
Satisfaction with care
10-item satisfaction with antenatal care index; 5 point Likert scale [1 (poor) and to 5 (excellent)], range 10-50, α =0.980
Healthcare utilization
Pre- and postnatal care attendance; health facility birth (yes/no), services received (21 items); content covered (18 items)
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.

Full Information

First Posted
September 13, 2018
Last Updated
April 11, 2023
Sponsor
University of Illinois at Chicago
Collaborators
University of Malawi, National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT03673709
Brief Title
Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi
Official Title
Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
University of Malawi, National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
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.
Allocation
Randomized
Enrollment
1776 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual Antenatal Care (usual care)
Arm Type
No Intervention
Arm Description
Women are provided antenatal care services on a first come, first serve basis and listen to a health lecture. They meet individually with a midwife for a physical assessment. Women complete laboratory tests (including HIV testing) at their first visit. Congruent with the new WHO recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.
Arm Title
Group Antenatal Care (intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Antenatal Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preterm birth
Description
Newborn born before 37 weeks gestational age
Time Frame
8 weeks postpartum
Title
Partner HIV Test
Description
Proportion of partners tested during this pregnancy
Time Frame
Enrollment, 36-42 weeks gestation
Secondary Outcome Measure Information:
Title
Spontaneous abortion
Description
Pregnancy loss less than 20 weeks
Time Frame
36-42 weeks gestation
Title
Stillbirth
Description
Baby born with no signs of life at or after 28 weeks gestational age
Time Frame
8 weeks postpartum
Title
Low birthweight
Description
Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth
Time Frame
8 weeks postpartum
Title
Neonatal death
Description
Newborn dies between 0-28 days after birth
Time Frame
8 weeks postpartum
Title
Maternal death
Description
Woman dies in pregnancy or within 42 days of the end of pregnancy
Time Frame
8 weeks postpartum, 6 months postpartum
Title
Woman HIV test
Description
Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy
Time Frame
Enrollment, 36-42 weeks gestation
Title
Anemia
Description
Hemoglobin
Time Frame
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Title
Postpartum bleeding
Description
Blood loss of greater than 500 ml (yes/no) or greater than 1000 ml (yes/no)
Time Frame
8 weeks postpartum
Title
Hypertension
Description
Blood pressure
Time Frame
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Title
Family planning
Description
Using a family planning method (yes/no)
Time Frame
8 weeks postpartum; 6 months postpartum
Title
Exclusive breastfeeding
Description
Duration in days
Time Frame
8 weeks postpartum; 6 months postpartum
Title
Early repeat pregnancy
Description
Negative pregnancy test and no reported pregnancy loss
Time Frame
8 weeks postpartum; 6 months postpartum
Title
ART medication (woman)
Description
Received medication from intake through six months postpartum
Time Frame
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Title
HIV test infant
Description
Infant tested for HIV and results received
Time Frame
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Title
Self Reporting Questionnaire (SRQ)
Description
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.
Time Frame
Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum
Title
Satisfaction with care
Description
10-item satisfaction with antenatal care index; 5 point Likert scale [1 (poor) and to 5 (excellent)], range 10-50, α =0.980
Time Frame
36-42 weeks gestation
Title
Healthcare utilization
Description
Pre- and postnatal care attendance; health facility birth (yes/no), services received (21 items); content covered (18 items)
Time Frame
36-42 weeks gestation; 8 weeks postpartum
Title
Adequate HIV knowledge
Description
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.
Time Frame
Enrollment, 36-42 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal L Patil, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangwe HC
City
Blantyre
Country
Malawi
Facility Name
Chileka HC
City
Blantyre
Country
Malawi
Facility Name
Chilomoni HC
City
Blantyre
Country
Malawi
Facility Name
Limbe HC
City
Blantyre
Country
Malawi
Facility Name
Lirangwe HC
City
Blantyre
Country
Malawi
Facility Name
Madziabango HC
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data will be made available to other researchers for secondary analyses after the primary outcome publications have been accepted for publication, approximately 3 years after the grant ends.
Citations:
PubMed Identifier
33098114
Citation
Liese KL, Kapito E, Chirwa E, Liu L, Mei X, Norr KF, Patil CL. Impact of group prenatal care on key prenatal services and educational topics in Malawi and Tanzania. Int J Gynaecol Obstet. 2021 Apr;153(1):154-159. doi: 10.1002/ijgo.13432. Epub 2020 Dec 2.
Results Reference
derived
PubMed Identifier
32039721
Citation
Chirwa E, Kapito E, Jere DL, Kafulafula U, Chodzaza E, Chorwe-Sungani G, Gresh A, Liu L, Abrams ET, Klima CS, McCreary LL, Norr KF, Patil CL. An effectiveness-implementation hybrid type 1 trial assessing the impact of group versus individual antenatal care on maternal and infant outcomes in Malawi. BMC Public Health. 2020 Feb 10;20(1):205. doi: 10.1186/s12889-020-8276-x.
Results Reference
derived

Learn more about this trial

Group Antenatal Care: Effectiveness and Contextual Factors Linked to Implementation Success in Malawi

We'll reach out to this number within 24 hrs