Work Description

Date: 05 December 2023

Dataset Title: Group Antenatal care and Delivery project (GRAND)

Dataset Creators: Lori, Jody R; Moyer, Cheryl; Lockhart, Nancy; Zielinski, Ruth E; Kukula, Vida; Apetorgbor, Veronica; Awini, Elizabeth; Badu-Gyan, Georgina; Williams, John

Dataset Contact: Jody R Lori jrlori@med.umich.edu

Key Points:
Antenatal care has the potential to play a pivotal role in ensuring positive pregnancy outcomes for both mothers and their newborns. While ANC is widely available and attended by the majority of pregnant women in Ghana, the expected impact on birth outcomes is yet to be fully realized.
Thus, it is vital to examine the way antenatal care is being delivered and to explore alternatives to the current model to enhance positive birth outcomes.

Research Overview:
GRAND is a five-year, cluster randomized controlled trial. The study is registered on ClinicalTrials.gov, [ID#: NCT04033003] and is a collaboration between University of Michigan in the United States and the Dodowa Health Research Center in Ghana.
The study setting for GRAND is four districts (Akwapim North, Yilo Krobo, Nsawam-Adoagyiri, and Lower Manya Krobo) within the Eastern Region of Ghana. Health facilities were selected based the number ANC registrants per month and average gestational age of women at registration in each facility.
Facilities were then matched based on facility type, district, and number of monthly ANC registrants.

Methodology:
A cluster randomized controlled trial was conducted in 14 facilities in four districts of the Eastern Region of Ghana. Health facilities were randomized using a matched pairs design; each pair was similar in the number of deliveries and average gestational age of the women at enrollment in antenatal care.
The locations of the facilities were far enough apart to avoid cross-group contamination. In each pair of facilities, one was randomly assigned to the intervention (G-ANC) and the other to the control (I-ANC). Recruitment began July 2019 and ended when enrollment targets were met.
Data collection ended July 2023 when data collection was complete.

Recruitment of women occurred at individual health facilities, with research staff working closely with clinic staff to identify women attending their first ANC visit and who met the eligibility criteria.
The criteria were as follows: (1) less than 20 weeks gestation, (2) speaks Dangme, Ga, Akan, Ewe, or English, (3) over the age of 15, and (4) not considered high risk.
Women meeting the eligibility criteria and who indicated an interest in learning more about the study to the midwife were instructed to talk to the research assistant (RA). The RA explained the study, and those women willing to participate were taken through an informed consent procedure.

Quantitative data was collected by trained RAs using encrypted and password protected tablets and REDCaP, a secure web application for data collection and data management. No data were collected by clinical providers.
Data collection occurs at five time points in both intervention and control arms. T0: Baseline (enrollment); T1: 3rd trimester (34 weeks gestation – 3 weeks post-delivery: T2: post-delivery (6-12 weeks after delivery); T3: 6-month follow up (5-8 months postpartum); T4: 1-year follow up (11-14 months postpartum).
We concurrently conducted a process evaluation to identify and document patient, provider, and system barriers and facilitators to program implementation. Using a mixed methods design that included qualitative data in the form of focus group discussions (FGDs), and individual interviews (II), quantitative data collected via observation during one of the later (5, 6 or 7) group ANC meetings and GANC attendance records.
Identifiers such as individual names, dates, and health facility names were removed to de-identify data.
De-identified data enclosed

Related Citations:
Lori JR, Williams JEO, Kukula VA, Apetorgbor VEA, Awini EA, Amankwah G, Zielinski R, Lockhart N, James KH, Moyer CA (2022) Group Antenatal Care in Ghana: Protocol for a Cluster Randomized Controlled Trial JMIR Res Protoc 11(9):e40828
URL: https://www.researchprotocols.org/2022/9/e4082 https://doi: 10.2196/40828

Zielinski R, Kukula V, Apetorgbor V, Awini E, Moyer C, Badu-Gyan G, et al. (2023) “With group antenatal care, pregnant women know they are not alone”: The process evaluation of a group antenatal care intervention in Ghana. PLoS ONE 18(11): e0291855. https://doi.org/10.1371/journal.pone.0291855
DeepBlue Data https://doi.org/10.7302/y9qf-az09

Lori, J., Kukula, V., Liu, L. et al. Improving health literacy through group antenatal care: results from a cluster randomized controlled trial in Ghana. BMC Pregnancy Childbirth 24, 37 (2024). https://doi.org/10.1186/s12884-023-06224-x

Files included as follows:
GRAND Study_readme.txt
GRAND Protocol.pdf
Informed Consent_GANC.pdf
Informed Consent_IANC.pdf
GRAND Survey_T0.pdf
GRAND Data Codebook_T0.csv
GRAND DATA_T0.csv
GRAND Survey_T1.pdf
GRAND Data Codebook_T1.csv
GRAND DATA_T1.csv
GRAND Survey_T2.pdf
GRAND Data Codebook_T2.csv
GRAND DATA_T2.csv
GRAND Survey_T3.pdf
GRAND Data Codebook_T3.csv
GRAND DATA_T3.csv
GRAND Survey_T4.pdf
GRAND Data Codebook_T4.csv
GRAND DATA_T4.csv
GRAND CONSORT Diagram_RCT.pdf

Use and Access:
This data set is made available under a Creative Commons Attribution license (CC BY 4.0).

Dataset citation:
Lori, J. R., Moyer, C., Lockhart, N., Zielinski, R. E., Kukula, V., Apetorgbor, V., Awini, E., Badu-Gyan, G., Williams, J. Group Antenatal care and Delivery project (GRAND) [Data set], University of Michigan - Deep Blue Data. https://doi.org/10.7302/d5ct-ne90