Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201706002254227 Date of Approval: 02/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Group ANC study in Kenya and Nigeria
Official scientific title Cluster randomized control trial to evaluate Group Antenatal Care (G-ANC) compared with routine individual antenatal care in Kenya and Nigeria
Brief summary describing the background and objectives of the trial Introduction: ANC in low-resource settings is often characterized with missed opportunities to provide information and optimal care to pregnant women in a timely manner. In busy ANC settings, women experience long waiting times for short, often rushed interactions with the health care provider leading to client dissatisfaction and sub-optimal care which may lead to reduced use of services in the future. Most women do not receive quality ANC under these circumstances - as defined by the proportion of pregnant women who received all eight recommended evidence-based interventions. Group ANC model of care originated in the United States as an innovative alternative to the traditional ANC model (i.e., provided by a skilled provider to one individual woman at a time) and as a means to improve womens knowledge, attendance, satisfaction, and health outcomes. In this proposed model, ANC is provided in facility-based groups of 8 -15 women of similar gestational age (sometimes with their partners or birth companions) through a series of meetings, usually provided by skilled health care providers (often midwives) in 1 -2 hour sessions. While there is growing evidence of the benefits of group ANC, the group care model has not yet been studied adequately to determine feasibility of implementation in a variety of settings; and if continued group care of the mother and baby during the first year after delivery also improves quality of care, satisfaction, and access to infant health and nutrition education, counseling, and care. This trial seeks to evaluate the acceptability (among clients and service providers), effectiveness, and feasibility of a group ANC model in two low-resource settings, namely Kenya and Nigeria compared to traditional ANC provided by a skilled provider to one individual woman at a time. Ultimately, the findings will be used to improve the quality and experience of facility-based ANC and promote retention in care thus optimizing health outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) G ANC study
Disease(s) or condition(s) being studied Family planning and hypertension,Infections and Infestations,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/07/2016
Actual trial start date 29/09/2016
Anticipated date of last follow up 30/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 2102
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
IRB00007078 Johns Hopkins School of Public Health IRB
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control arm-Kenya Each women will be receive the usual ANC care provided which is individual consultations with a service providers; four ANC visits and at least one PNC visit during the PNC period. 17 month follow-up period Pregnant women who meet the eligibility criteria and consent to participate will be enrolled and followed up as they continue with the ¿usual standard of ANC and PNC care¿ whereby service providers attended to each woman one-at-a-time. There will be NO group interaction. The Kenya MOH guidelines for providing ANC and PNC care will be followed. 513 Historical
Experimental Group Group ANC-Nigeria Each cohort will meet for 2 hours once a month before they deliver (ANC phase) ¿ 5 sessions. The same cohort will meet once every 3 months after delivery until 12 months thus 4 meetings (PNC phase). 17 months follow-up Pregnant women who meet the eligibility criteria and consent to participate will be assigned to groups or cohorts of 8-15 women. The women in the group should be 20-24 weeks gestation age at the time of first cohort meeting and continue meeting at the health facility during pregnancy (ANC Phase). They meet again after 2-3 month following delivery, meet for 4 times 12 months (PNC phase). 538
Control Group Control arm-Nigeria Each women will be receive the usual ANC care provided which is individual consultations with a service providers; four ANC visits and at least one PNC visit during the PNC period. 17 month follow-up period Pregnant women who meet the eligibility criteria and consent to participate will be enrolled and followed up as they continue with the ¿usual standard of ANC and PNC care¿ whereby service providers attended to each woman one-at-a-time. There will be NO group interaction. The Kenya MOH guidelines for providing ANC and PNC care will be followed. 538 Historical
Experimental Group G-ANC arm - Kenya Each cohort will meet for 2 hours once a month before they deliver (ANC phase) ¿ 5 sessions. The same cohort will meet once every 3 months after delivery until 12 months thus 4 meetings (PNC phase). 17 month follow-up period Pregnant women who meet the eligibility criteria and consent to participate will be assigned to groups or cohorts of 8-15 women. The women in the group should be 20-24 weeks gestation age at the time of first cohort meeting and continue meeting at the health facility during pregnancy (ANC Phase). They meet again after 2-3 month following delivery, meet for 4 times for 12 months (PNC phase) 513 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Gestational age between <24 weeks at the time of first group meeting determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test Pregnant women able and willing to provide adequate locator information Planning to reside at their current location for at least 18 months Willing to participate and consent to follow up for up to 12 months post-delivery Women who plan to travel away from the study site for more than four consecutive weeks during antenatal care and 12 consecutive weeks during postnatal care Women who are unable provide consent Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives 15 Year(s) 49 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/06/2016 KEMRI ERC
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840 00200 Off Mbagathi Road Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/04/2016 Ministry of Health, Nasarawa state
Ethics Committee Address
Street address City Postal code Country
Private mail bag 032 Lafia Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/04/2016 Johns Hopkins School of Public Health IRB
Ethics Committee Address
Street address City Postal code Country
615 N Wolfe St Baltimore 21205 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Skilled birth attendance Three to six weeks after the women give birth
Secondary Outcome Effects of group ANC and PNC participation on the uptake of ANC and PNC services and related health behaviors (e.g., iron and folic acid [IFA] supplementation, use of long lasting insecticide treated nets [LLIN], completed individual birth plan, exclusive breastfeeding, and use of postpartum family planning). Time point 1: 3-6 months after women give birth Time point 2: 12 months after giving birth.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nasarawa state, Nigeria Nasarawa State Lafia - HQ of the state 001 Nigeria
Kisumu County, Kenya Prosperity house - Kisumu county headquarters Kisumu 40100 Kenya
Machakos County, Kenya Mwatu wa Ngoma - Machackos county headquarters Machakos 90100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 440 5th Ave N, Seattle, WA 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jhpiego 1615 Thames Street Baltimore 21231 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Private Mail Bag 032 Lafia, Nasarawa state 001 Nigeria
Ministry of Health Machackos and Kisumu Counties Kenya
Ministry of Health - Kisumu County Kisumu county headquarters Kisumu 40100 Kenya
Ministry of Health - Machakos County Machackos county headquarters Machakos 90100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jeffrey Michael Smith Jeffrey.Smith@jhpiego.org 415371896 1615 Thames Street
City Postal code Country Position/Affiliation
Baltimore 21231 United States of America Vice President, TLO
Role Name Email Phone Street address
Public Enquiries Grenier Lindsay Lindsay.Grenier@jhpiego.org 4105371900 1615 Thames Street
City Postal code Country Position/Affiliation
Baltimore 21231 United States of America Project Director
Role Name Email Phone Street address
Scientific Enquiries Mark Kabue Mark.Kabue@jhpiego.org 4105371990 1615 Thames Street
City Postal code Country Position/Affiliation
Baltimore 21231 United States of America Snr. M&E Advisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 27/05/2017 New information 15 15
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 27/05/2017 New information 49 49
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 30/05/2017 edit 2252 2102
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 27/05/2017 New information ¿ Women who plan to travel away from the study site for more than four consecutive weeks during antenatal care and 12 consecutive weeks during postnatal care ¿ Women who are unable provide consent ¿ Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives Women who plan to travel away from the study site for more than four consecutive weeks during antenatal care and 12 consecutive weeks during postnatal care Women who are unable provide consent Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 27/05/2017 New information ¿ Gestational age between <24 weeks at the time of first group meeting determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test ¿ Pregnant women able and willing to provide adequate locator information ¿ Planning to reside at their current location for at least 18 months ¿ Willing to participate and consent to follow up for up to 12 months post-delivery Gestational age between <24 weeks at the time of first group meeting determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test Pregnant women able and willing to provide adequate locator information Planning to reside at their current location for at least 18 months Willing to participate and consent to follow up for up to 12 months post-delivery
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Sex 27/05/2017 New information Female Female
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 05/07/2018 pactr update Introduction: ANC in low-resource settings is often characterized with missed opportunities to provide information and optimal care to pregnant women in a timely manner. In busy ANC settings, women experience long waiting times for short, often rushed interactions with the health care provider leading to client dissatisfaction and sub-optimal care which may lead to reduced use of services in the future. Most women do not receive quality ANC under these circumstances - as defined by the proportion of pregnant women who received all eight recommended evidence-based interventions. Group ANC model of care originated in the United States as an innovative alternative to the traditional ANC model (i.e., provided by a skilled provider to one individual woman at a time) and as a means to improve women¿s knowledge, attendance, satisfaction, and health outcomes. In this proposed model, ANC is provided in facility-based groups of 8¿15 women of similar gestational age (sometimes with their partners or birth companions) through a series of meetings, usually provided by skilled health care providers (often midwives) in 1¿2 hour sessions. While there is growing evidence of the benefits of group ANC, the group care model has not yet been studied adequately to determine feasibility of implementation in a variety of settings; and if continued group care of the mother and baby during the first year after delivery also improves quality of care, satisfaction, and access to infant health and nutrition education, counseling, and care. This trial seeks to evaluate the acceptability (among clients and service providers), effectiveness, and feasibility of a group ANC model in two low-resource settings¿Kenya and Nigeria¿compared to traditional ANC provided by a skilled provider to one individual woman at a time. Ultimately, the findings will be used to improve the quality and experience of facility-based ANC and promote retention in care thus optimizing health outcomes. Introduction: ANC in low-resource settings is often characterized with missed opportunities to provide information and optimal care to pregnant women in a timely manner. In busy ANC settings, women experience long waiting times for short, often rushed interactions with the health care provider leading to client dissatisfaction and sub-optimal care which may lead to reduced use of services in the future. Most women do not receive quality ANC under these circumstances - as defined by the proportion of pregnant women who received all eight recommended evidence-based interventions. Group ANC model of care originated in the United States as an innovative alternative to the traditional ANC model (i.e., provided by a skilled provider to one individual woman at a time) and as a means to improve womens knowledge, attendance, satisfaction, and health outcomes. In this proposed model, ANC is provided in facility-based groups of 8 -15 women of similar gestational age (sometimes with their partners or birth companions) through a series of meetings, usually provided by skilled health care providers (often midwives) in 1 -2 hour sessions. While there is growing evidence of the benefits of group ANC, the group care model has not yet been studied adequately to determine feasibility of implementation in a variety of settings; and if continued group care of the mother and baby during the first year after delivery also improves quality of care, satisfaction, and access to infant health and nutrition education, counseling, and care. This trial seeks to evaluate the acceptability (among clients and service providers), effectiveness, and feasibility of a group ANC model in two low-resource settings, namely Kenya and Nigeria compared to traditional ANC provided by a skilled provider to one individual woman at a time. Ultimately, the findings will be used to improve the quality and experience of facility-based ANC and promote retention in care thus optimizing health outcomes.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 05/07/2018 pactr update G-ANC study G ANC study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 pactr update Other Pregnancy and Childbirth, Other
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Other disease 05/07/2018 pactr update Family planning; hypertension Family planning and hypertension