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Clinical trialNCT04033003CompletedInterventional

Group Antenatal Care and Delivery Project

SponsorUniversity of MichiganEnrollment1,761Antenatal Care
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Antenatal care (ANC) has the potential to play a pivotal role in ensuring positive pregnancy outcomes for both mothers and their newborns. A critical component of all ANC is teaching women to recognize the major complications that account for the majority of preventable maternal and newborn deaths. Antenatal care provides an opportunity to promote a healthy lifestyle, to integrate positive health behaviors, and to develop a trusting relationship with a provider and the health system. While group ANC has been delivered and studied in high-resource settings for over a decade, it has only recently been introduced as an alternative to individual care in sub-Saharan Africa. The goal of this research is to improve health literacy and reduce preventable maternal and newborn morbidities and mortality within highly vulnerable, low and non-literate populations that assume a disproportionate burden of poor pregnancy outcomes globally. This research examines a bold, new approach to ANC that takes provision of care out of clinic exam rooms into small groups of women grouped by gestational age in low resource settings with low and non-literate populations. Group ANC has the potential to shift the current clinical practice paradigm of antenatal care for highly vulnerable women to improve maternal and newborn outcomes both globally and domestically. The investigators hypothesize that pregnant women randomized into group ANC will exhibit increased health literacy through: 1) increased birth preparedness and complication readiness (BPCR), including recognition of danger signs and knowledge of how to respond to such signs; 2) higher rates of care-seeking behaviors, including seeking care for problems identified during pregnancy, higher facility delivery rates, and increased attendance at postnatal and postpartum care; and 3) better clinical outcomes for themselves and their newborns than women who received the routine, individual ANC.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Ghana
  • Adawso Health Center

    Adawso, Ghana

  • Adukrom Health Center

    Adukrom, Ghana

  • Klo Agogo Polyclinic

    Agogo, Ghana

  • Abiriw Clinic

    Akropong, Ghana

  • St Martin'S Hospital

    Akropong, Ghana

  • Akuse Hospital

    Akuse, Ghana

  • Nkurakan Health Center

    Koforidua, Ghana

  • Tetteh Quarshie Hospital

    Mampong, Ghana

  • Adoagyiri Health Center

    Nsawam, Ghana

  • Djankrom Health Center

    Nsawam, Ghana

  • Nsawam Health Center

    Nsawam, Ghana

  • Nsawam Hospital

    Nsawam, Ghana

  • Atua Hospital

    Somanya, Ghana

  • Somanya Polyclinic

    Somanya, Ghana

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Jul 2019
Primary completion
18 Aug 2022
Completion
26 Jun 2023
Last update posted
7 Jun 2024
Registered enrollment
1,761
Registry id
NCT04033003

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.