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N/A N=1,761 Randomized Treatment

Group Antenatal Care and Delivery Project

Antenatal Care

Enrolled (actual)
1,761
Serious AEs
0.3%
Results posted
Sep 2023
Primary outcome: Primary: Change in Ability to Identify Danger Signs in Pregnancy — 1.8; 1.7; 3.4; 2.2 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group ANC (Behavioral)
Age
Pediatric, Adult, Older Adult · 15+ yrs
Sex
Female
Sponsor
University of Michigan
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Ability to Identify Danger Signs in Pregnancy
1.8; 1.7; 3.4; 2.2
PRIMARY
Change in Birth Preparedness and Complication Readiness
1.4; 1.42; 2.9; 1.7
PRIMARY
Change in Ability to Identify Newborn Danger Signs
1.9; 1.5; 1.8; 2.8
PRIMARY
Attendance of ANC Visits
555; 523; 2; 3
PRIMARY
Place of Delivery
567; 567; 18; 26
PRIMARY
Attendance at Postpartum Check-ups for Mother
392; 451; 469; 447; 517; 541
PRIMARY
Attendance at Postnatal Check-up for Newborn
412; 460; 473; 453; 531; 550
PRIMARY
Birth Outcome
580; 587; 5; 8; 6; 7
PRIMARY
Change in Health Literacy
9.6; 9.7; 11.3; 11
SECONDARY
Change in Ability to Identify Postpartum Danger Signs for Mother
1.26; 1.17; 2.44; 1.69
SECONDARY
Change in Ability to Identify the Recommended Action Steps When a Problem is Identified
671; 636; 206; 248; 594; 552
SECONDARY
Change in Knowledge of Family Planning Methods
2.22; 2.01; 3.88; 2.37
SECONDARY
Change in Intent to Use Family Planning
0.38; 0.41; 0.61; 0.42
SECONDARY
Change in Uptake of Family Planning
0.15; 0.09; 0.25; 0.2; 0.35; 0.43
SECONDARY
Change in Interpersonal Violence
4.48; 4.59; 4.62; 4.78
SECONDARY
Experience of ANC Care
20.1; 18.79
SECONDARY
Completion of IPTp2 Malaria Prophylaxis During Pregnancy
375; 419; 237; 238
SECONDARY
Completion of Least Two Tetanus Toxoid Vaccines During Pregnancy
487; 518; 124; 142
SECONDARY
Newborn Weight
459; 431; 33; 38
SECONDARY
Mother's Hemoglobin at Delivery in Grams Per Deciliter (g/dl).
4; 3; 176; 177; 311; 313

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • willingness to participate in the study
  • less than 20 weeks' gestation 3) able to speak Dangme, Ga, Akan, Ewe, or English
  • over the age of 15 years

Exclusion Criteria

  • No history of medical problems that would indicate the participant might be considered "high risk" (e.g., hypertension, insulin-dependent diabetes mellitus) and thus requiring a more individualized approach to care.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04033003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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