Crystal L Patil1, Carrie S Klima1, Alana D Steffen2, Sebalda C Leshabari3, Heather Pauls4, Kathleen F Norr1. 1. Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA. 2. Department of Health Systems Science, University of Illinois at Chicago, Chicago, IL, USA. 3. Department of Community Health Sciences, School of Nursing, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. 4. Office of Research Facilitation, University of Illinois at Chicago, Chicago, IL, USA.
Abstract
OBJECTIVE: To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. METHODS: A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. RESULTS: The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). CONCLUSION: Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.
RCT Entities:
OBJECTIVE: To identify implementation challenges associated with conducting a randomized controlled trial (RCT) of group prenatal care (PNC) and report outcomes of the pilot. METHODS: A multi-site randomized pilot was conducted in Malawi and Tanzania between July 31, 2014, and June 30, 2015. Women aged at least 16 years with a pregnancy of 20-24 weeks were randomly assigned using sealed envelopes (1:1) to individual or group PNC. Structured interviews were conducted at baseline, in the third trimester and 6-8 weeks after delivery. The primary outcomes were attendance at four PNC visits and attendance at the 6-week postnatal visit. RESULTS: The pilot showed that an RCT with individual randomization can be conducted in these two low-resource settings. Significantly more women in group PNC than in individual PNC completed at least four PNC visits (96/102 [94.1%] vs 53/91 [58.2%]) and attended the postnatal visit (76/102 [74.5%] vs 45/90 [50.0%]; both P<0.001). CONCLUSION: Group PNC was feasible and associated with an increase in healthcare utilization and improved outcomes in Malawi and Tanzania. Lessons learned should be considered when designing large RCTs to determine efficacy. ClinicalTrials.gov: NCT02999334.
Authors: Paul Conrad; Manuela De Allegri; Arinaitwe Moses; Elin C Larsson; Florian Neuhann; Olaf Müller; Malabika Sarker Journal: Qual Health Res Date: 2012-01-09
Authors: J Villar; H Ba'aqeel; G Piaggio; P Lumbiganon; J Miguel Belizán; U Farnot; Y Al-Mazrou; G Carroli; A Pinol; A Donner; A Langer; G Nigenda; M Mugford; J Fox-Rushby; G Hutton; P Bergsjø; L Bakketeig; H Berendes; J Garcia Journal: Lancet Date: 2001-05-19 Impact factor: 79.321
Authors: Crystal L Patil; Elizabeth T Abrams; Carrie Klima; Chrissie P N Kaponda; Sebalda C Leshabari; Susan C Vonderheid; Martha Kamanga; Kathleen F Norr Journal: Midwifery Date: 2013-07-19 Impact factor: 2.372
Authors: Joshua P Vogel; Ndema Abu Habib; João Paulo Souza; A Metin Gülmezoglu; Therese Dowswell; Guillermo Carroli; Hassan S Baaqeel; Pisake Lumbiganon; Gilda Piaggio; Olufemi T Oladapo Journal: Reprod Health Date: 2013-04-12 Impact factor: 3.223
Authors: Felix Sayinzoga; Tiffany Lundeen; Sabine F Musange; Elizabeth Butrick; David Nzeyimana; Nathalie Murindahabi; Hana Azman-Firdaus; Nancy L Sloan; Alejandra Benitez; Beth Phillips; Rakesh Ghosh; Dilys Walker Journal: PLoS One Date: 2021-02-02 Impact factor: 3.240
Authors: Crystal L Patil; Carrie S Klima; Sebalda C Leshabari; Alana D Steffen; Heather Pauls; Molly McGown; Kathleen F Norr Journal: BMC Pregnancy Childbirth Date: 2017-11-08 Impact factor: 3.007
Authors: Lindsay Grenier; Stephanie Suhowatsky; Mark M Kabue; Lisa M Noguchi; Diwakar Mohan; Shalmali Radha Karnad; Brenda Onguti; Eunice Omanga; Anthony Gichangi; Jonesmus Wambua; Charles Waka; Jaiyeola Oyetunji; Jeffrey M Smith Journal: PLoS One Date: 2019-10-02 Impact factor: 3.240
Authors: Ellen Chirwa; Esnath Kapito; Diana L Jere; Ursula Kafulafula; Elizabeth Chodzaza; Genesis Chorwe-Sungani; Ashley Gresh; Li Liu; Elizabeth T Abrams; Carrie S Klima; Linda L McCreary; Kathleen F Norr; Crystal L Patil Journal: BMC Public Health Date: 2020-02-10 Impact factor: 3.295
Authors: Mark M Kabue; Lindsay Grenier; Stephanie Suhowatsky; Jaiyeola Oyetunji; Emmanuel Ugwa; Brenda Onguti; Eunice Omanga; Anthony Gichangi; Jonesmus Wambua; Charles Waka; Joseph Enne; Jennyfer Don-Aki; Mairo Ali; Maryam Buba; Jenipher Ang'aha; Daniel Iya; Elizabeth Washika; Diwakar Mohan; Jeffrey M Smith Journal: Gates Open Res Date: 2018-11-05