Premature BirthNCT03673709

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

A study testing Antenatal Care in people with Premature Birth, run by University of Illinois at Chicago at 7 sites in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Premature Birth
What is being tested?: Antenatal Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,887 participants
Where: 7 sitesMalawi
Study dates: 5 Jul 2019to 31 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)

Who cannot join

Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Malawi7 sites

Bangwe HC
Blantyre
Chileka HC
Blantyre
Chilomoni HC
Blantyre
Limbe HC
Blantyre
Lirangwe HC
Blantyre
Madziabango HC
Blantyre
Ndirande HC
Blantyre

Other trials in Malawi

About this study

Official title: Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi

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.

Read the 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.

Conditions: Premature Birth
Being tested: Antenatal Care
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Antenatal CareBehavioural
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.

Study groups in NCT03673709
Study group	Role	What they receive
Individual Antenatal Care (usual care)	No intervention	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 World Health Organization (WHO) recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.
Group Antenatal Care (intervention)	Experimental	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. Receives: Behavioral: Antenatal Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Born Weighing Less Than 2500 g
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.
Measured: 8 weeks postpartum
Partner HIV Test
Proportion of partners tested during this pregnancy
Measured: 36-42 weeks gestation

Secondary outcomes (14)

Spontaneous Abortion
Pregnancy loss less than 20 weeks
Measured: 36-42 weeks gestation
Stillbirth
Baby born with no signs of life at or after 28 weeks gestational age
Measured: 8 weeks postpartum
Infant Death
Infant death before the end of the study
Measured: 6 months postpartum
Maternal Death
Maternal death before the end of the study
Measured: 6 months postpartum
Anemia
Hemoglobin level of <11 g/dl
Measured: 36-42 weeks gestation
Family Planning
Reported use of family planning at late postpartum, approximately 6 months after delivery
Measured: 6 months postpartum
Exclusive Breastfeeding
Exclusive breastfeeding for six months (yes)
Measured: 6 months postpartum
Self Reporting Questionnaire (SRQ)
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.
Measured: 8 weeks postpartum
Satisfaction With Antenatal Care (ANC)
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.
Measured: 36-42 weeks gestation
Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct
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).
Measured: 36-42 weeks gestation
Mean Antenatal Care (ANC) Contacts
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
Measured: 8 weeks postpartum
Pregnancy-related Empowerment Scale (PRES)
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.
Measured: 36 to 42 weeks gestation
Wait Time
Waited less than one hour for antenatal care (ANC) services (% yes)
Measured: 36-42 weeks gestation
Prefer Group Antenatal Care (ANC) in the Future
In late pregnancy, participants were asked if they would prefer individual or group antenatal care (ANC) if pregnant in the future (% preferring group ANC).
Measured: 36-42 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201931 May 2024

First posted17 Sep 2018
Study start5 Jul 2019
Primary completion10 Aug 2023
Study completion31 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Premature BirthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,887 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03673709
Sponsor's protocol ID: 2018-0845
Other IDs: R01NR018115
Status last verified: Jun 2026
First submitted: 13 Sep 2018
Last updated: 13 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Patil CL, Norr KF, Kapito E, Liu LC, Mei X, Chodzaza E, Chorwe-Sungani G, Kafulafula U, Abrams ET, Desloge A, Gresh A, Jeremiah RD, Patel DR, Batchelder A, Wang H, Faydenko J, Rising SS, Chirwa E. Group antenatal care positively transforms the care experience: Results of an effectiveness trial in Malawi. PLoS One. 2025 Jun 18;20(6):e0317171. doi: 10.1371/journal.pone.0317171. eCollection 2025.
PubMed 40531963
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.
PubMed 33098114
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.
PubMed 32039721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Premature Birth trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Group Antenatal Care: Effectiveness for Maternal/Infant and HIV Prevention Outcomes and Contextual Factors Linked to Implementation Success in Malawi
ClinicalTrials.gov ID: NCT03673709
Acronym / sponsor ID: 2018-0845
Conditions: Premature Birth
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,887 participants (actual)
Lead sponsor: University of Illinois at ChicagoUniversity, hospital or other
Collaborators: University of Malawi, National Institute of Nursing Research (NINR)
Study start: 5 Jul 2019 (actual)
Primary completion: 10 Aug 2023 (actual)
Study completion: 31 May 2024 (actual)
First posted: 17 Sep 2018 (actual)
Results: Posted 13 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Individual Antenatal Care (usual care)	No intervention	–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 World Health Organization (WHO) recommendations, individual antenatal care consists of 8 antenatal care visits and 2 postnatal visits at 1 week and 6 weeks.
Group Antenatal Care (intervention)	Experimental	Behavioral: Antenatal CareWomen 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.

Who may qualify

Ages: 15 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Pregnant, 24 weeks gestation or less, no marked cognitive impairment, speaks and understands Chichewa (the national language)

Key exclusion criteria (1 listed)

Not pregnant, more than 24 weeks gestation, marked cognitive impairment, does not speak or understand Chichewa (the national language)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Antenatal CareWomen 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.	Behavioural	Group Antenatal Care (intervention)

Primary outcome

Born Weighing Less Than 2500 g
Time frame: 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
Time frame: 36-42 weeks gestation
Proportion of partners tested during this pregnancy

14 secondary outcomes

Spontaneous Abortion
Time frame: 36-42 weeks gestation
Stillbirth
Time frame: 8 weeks postpartum
Infant Death
Time frame: 6 months postpartum
Maternal Death
Time frame: 6 months postpartum
Anemia
Time frame: 36-42 weeks gestation
Family Planning
Time frame: 6 months postpartum
Exclusive Breastfeeding
Time frame: 6 months postpartum
Self Reporting Questionnaire (SRQ)
Time frame: 8 weeks postpartum
Satisfaction With Antenatal Care (ANC)
Time frame: 36-42 weeks gestation
Joint United Nations Programme on HIV/AIDS (UNAIDS) Comprehensive Knowledge, All Correct
Time frame: 36-42 weeks gestation
Mean Antenatal Care (ANC) Contacts
Time frame: 8 weeks postpartum
Pregnancy-related Empowerment Scale (PRES)
Time frame: 36 to 42 weeks gestation
Wait Time
Time frame: 36-42 weeks gestation
Prefer Group Antenatal Care (ANC) in the Future
Time frame: 36-42 weeks gestation

Results and safety

Results posted to the registry on 13 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Individual Antenatal Care	941	747
Group Antenatal Care	946	767

Primary outcome: Born Weighing Less Than 2500 g

Time frame: 8 weeks postpartum. Count of participants. Unit: Participants

Measure	Individual Antenatal Care (Usual Care) n = 766	Group Antenatal Care (Intervention) n = 792
Yes, less than 2500 grams	73	87
No, not less than 2500 grams	693	705

Primary outcome: Partner HIV Test

Time frame: 36-42 weeks gestation. Count of participants. Unit: Participants

Measure	Individual Antenatal Care (Usual Care) n = 791	Group Antenatal Care (Intervention) n = 816
Value	594	644

Population analysed: The number does not reflect the total in Participant Flow due to missing data and exclusion of participants who identified as HIV positive, so would not need to be tested for HIV

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: The specific time period was 1 year, from baseline (in mid-pregnancy) until the end of follow-up at 6 months postpartum.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Individual Antenatal Care Women	0 of 941 (0%)	0 of 941 (0%)	0 of 941
Individual Antenatal Care Infants	0 of 815 (0%)	0 of 815 (0%)	16 of 815
Group Antenatal Care Women	0 of 946 (0%)	0 of 946 (0%)	1 of 946
Group Antenatal Care Infants	0 of 848 (0%)	0 of 848 (0%)	22 of 848

Limitations and caveats (from the sponsor): We originally intended to assess the impact of Group ANC on preterm birth rates, which requires an accurate assessment of gestational age at birth. After integrating all available data from health records and women's reports (i.e., last menstrual period, midwife assessments, and ultrasound results), we were still unable to obtain a reliable measure of gestational age at birth, even when ultrasound results were available. Therefore, we opted to use low birth weight as a proxy for this outcome

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40531963Patil CL, Norr KF, Kapito E, Liu LC, Mei X, Chodzaza E, Chorwe-Sungani G, Kafulafula U, Abrams ET, Desloge A, Gresh A, Jeremiah RD, Patel DR, Batchelder A, Wang H, Faydenko J, Rising SS, Chirwa E. Group antenatal care positively transforms the care experience: Results of an effectiveness trial in Malawi. PLoS One. 2025 Jun 18;20(6):e0317171. doi: 10.1371/journal.pone.0317171. eCollection 2025.
Derived from this study: PubMed 33098114Liese 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.
Derived from this study: PubMed 32039721Chirwa 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.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Crystal L Patil, PhD principal investigator

University of Illinois at Chicago

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Antenatal Care in people with Premature Birth, run by University of Illinois at Chicago at 7 sites in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Born Weighing Less Than 2500 g (time frame: 8 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03673709, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.