NCT02999334

Brief Summary

The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe resource and staffing shortages. The investigators adapted and piloted an evidence-based model of group antenatal care as an innovative way to improve ANC service delivery and increase health promotion. This pilot will be conducted in Malawi and Tanzania and will provide data to prepare for a large randomized controlled trial to document the impacts that group antenatal has on perinatal health outcomes. This study will ultimately inform policy and practice aimed at improving quality of antenatal care through respectful and woman-centered care to pregnant women.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

December 11, 2016

Last Update Submit

December 16, 2016

Conditions

Prenatal Care

Keywords

Group healthcare modelsAntenatal carePrenatal carePerinatal healthCenteringPregnancysub-Saharan AfricaMalawiTanzaniaPregnancy

Outcome Measures

Primary Outcomes (1)

  • Adherence to Care

    Two Indicators: Attended 4 (or more) antenatal care visits (yes, no) and the 6-week postnatal visit (yes, no)

    6-8 weeks postpartum

Secondary Outcomes (8)

  • Healthy Pregnancy Knowledge Index

    Enrollment, 32-40 weeks gestation

  • Healthy Pregnancy Behaviors

    Enrollment, 32-40 weeks gestation

  • Prevention of Mother-to-Child (PMTCT) Knowledge

    Enrollment, 32-40 weeks gestation

  • Comprehensive HIV Prevention Knowledge

    Enrollment, 32-40 weeks gestation

  • Mental Distress

    Enrollment, 32-40 weeks gestation

  • +3 more secondary outcomes

Study Arms (2)

Individual ANC (standard care)

NO INTERVENTION

Individual ANC is the standard of care. Women arrive at the clinic and and are provided ANC services on a first come, first serve basis. While waiting women who are present listen to a health lecture. Women then complete laboratory tests, including HIV testing (at the first visit), then meet individually with a midwife for a brief one-on-one physical assessment. Four ANC visits are recommended.

Group ANC (intervention)

EXPERIMENTAL

Women in CP-based group antenatal care (intervention) arrive at clinic at the scheduled appointment time and go directly to the group space. The same group of 12 women and the midwife and co-facilitator are present at each session. Women measure and record their own vital signs and weight. Each then has a brief one-on-one assessment with the midwife in the group space room. Instead of health lectures, the group engages in facilitated and interactive discussions using activities. Four ANC visits are recommended.

Behavioral: Group Antenatal Care

Interventions

Group Antenatal CareBEHAVIORAL

To examine the effect of type of care on completion of the recommended antenatal and postnatal visits as well as perinatal health outcomes, including knowledge, behaviors, psychosocial well-being, pregnancy-related empowerment, satisfaction with ANC care.

Group ANC (intervention)

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Physically and mentally competent pregnant women over the age of 16 attending antenatal care

You may not qualify if:

  • Less than 16 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Patil CL, Abrams ET, Klima C, Kaponda CP, Leshabari SC, Vonderheid SC, Kamanga M, Norr KF. CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals. Midwifery. 2013 Oct;29(10):1190-8. doi: 10.1016/j.midw.2013.05.008. Epub 2013 Jul 19.

    PMID: 23871278RESULT

  • 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.

    PMID: 33098114DERIVED

  • Patil CL, Klima CS, Steffen AD, Leshabari SC, Pauls H, Norr KF. Implementation challenges and outcomes of a randomized controlled pilot study of a group prenatal care model in Malawi and Tanzania. Int J Gynaecol Obstet. 2017 Dec;139(3):290-296. doi: 10.1002/ijgo.12324. Epub 2017 Oct 10.

    PMID: 28905377DERIVED

Study Officials

  • Crystal L Patil, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 21, 2016

Study Start

September 1, 2013

Primary Completion

May 1, 2015

Study Completion

August 1, 2016

Last Updated

December 21, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share