TY - JOUR
T1 - Group versus individual antenatal and first year postpartum care
T2 - Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria
AU - Kabue, Mark M.
AU - Grenier, Lindsay
AU - Suhowatsky, Stephanie
AU - Oyetunji, Jaiyeola
AU - Ugwa, Emmanuel
AU - Onguti, Brenda
AU - Omanga, Eunice
AU - Gichangi, Anthony
AU - Wambua, Jonesmus
AU - Waka, Charles
AU - Enne, Joseph
AU - Don-Aki, Jennyfer
AU - Ali, Mairo
AU - Buba, Maryam
AU - Ang’aha, Jenipher
AU - Iya, Daniel
AU - Washika, Elizabeth
AU - Mohan, Diwakar
AU - Smith, Jeffrey M.
N1 - Funding Information:
The study was funded by the Bill and Melinda Gates Foundation [OPP1134962].
Publisher Copyright:
© 2019 Kabue MM et al.
PY - 2018
Y1 - 2018
N2 - Background: Antenatal care (ANC) in many low-and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum.
AB - Background: Antenatal care (ANC) in many low-and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum.
KW - Experience of care
KW - Facility-based delivery
KW - Group antenatal care
KW - Health literacy
KW - Kenya
KW - Nigeria
KW - Postpartum family planning
KW - Self-efficacy
UR - http://www.scopus.com/inward/record.url?scp=85072797483&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072797483&partnerID=8YFLogxK
U2 - 10.12688/gatesopenres.12867.2
DO - 10.12688/gatesopenres.12867.2
M3 - Article
C2 - 30706056
AN - SCOPUS:85072797483
SN - 2572-4754
VL - 2
JO - Gates Open Research
JF - Gates Open Research
M1 - 56
ER -