Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03673709
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : April 13, 2023
Sponsor:
Collaborators:
University of Malawi
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Crystal L. Patil, PhD, 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.

Condition or disease Intervention/treatment Phase
Premature Birth Behavioral: Antenatal Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Health Services Research
Official Title: Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Individual Antenatal Care (usual care)
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.
Experimental: Group Antenatal Care (intervention)
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.
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.




Primary Outcome Measures :
  1. Preterm birth [ Time Frame: 8 weeks postpartum ]
    Newborn born before 37 weeks gestational age

  2. Partner HIV Test [ Time Frame: Enrollment, 36-42 weeks gestation ]
    Proportion of partners tested during this pregnancy


Secondary Outcome Measures :
  1. Spontaneous abortion [ Time Frame: 36-42 weeks gestation ]
    Pregnancy loss less than 20 weeks

  2. Stillbirth [ Time Frame: 8 weeks postpartum ]
    Baby born with no signs of life at or after 28 weeks gestational age

  3. Low birthweight [ Time Frame: 8 weeks postpartum ]
    Newborn weighing less than 2.5 kg or 2500 grams, measured within 24 hours of birth

  4. Neonatal death [ Time Frame: 8 weeks postpartum ]
    Newborn dies between 0-28 days after birth

  5. Maternal death [ Time Frame: 8 weeks postpartum, 6 months postpartum ]
    Woman dies in pregnancy or within 42 days of the end of pregnancy

  6. Woman HIV test [ Time Frame: Enrollment, 36-42 weeks gestation ]
    Initial HIV test, if seronegative then repeated in 3rd trimester of pregnancy

  7. Anemia [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]
    Hemoglobin

  8. Postpartum bleeding [ Time Frame: 8 weeks postpartum ]
    Blood loss of greater than 500 ml (yes/no) or greater than 1000 ml (yes/no)

  9. Hypertension [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]
    Blood pressure

  10. Family planning [ Time Frame: 8 weeks postpartum; 6 months postpartum ]
    Using a family planning method (yes/no)

  11. Exclusive breastfeeding [ Time Frame: 8 weeks postpartum; 6 months postpartum ]
    Duration in days

  12. Early repeat pregnancy [ Time Frame: 8 weeks postpartum; 6 months postpartum ]
    Negative pregnancy test and no reported pregnancy loss

  13. ART medication (woman) [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]
    Received medication from intake through six months postpartum

  14. HIV test infant [ Time Frame: Enrollment, 36-42 weeks gestation; 8 weeks postpartum, 6 months postpartum ]
    Infant tested for HIV and results received

  15. Self Reporting Questionnaire (SRQ) [ Time Frame: 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.

  16. Satisfaction with care [ Time Frame: 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

  17. Healthcare utilization [ Time Frame: 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)

  18. Adequate HIV knowledge [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673709


Locations
Layout table for location information
Malawi
Bangwe HC
Blantyre, Malawi
Chileka HC
Blantyre, Malawi
Chilomoni HC
Blantyre, Malawi
Limbe HC
Blantyre, Malawi
Lirangwe HC
Blantyre, Malawi
Madziabango HC
Blantyre, Malawi
Sponsors and Collaborators
University of Illinois at Chicago
University of Malawi
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Crystal L Patil, PhD University of Illinois at Chicago
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Crystal L. Patil, PhD, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03673709    
Other Study ID Numbers: 2018-0845
R01NR018115 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: April 13, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases