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.: PACTR201609001784334 Date of Approval: 17/09/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until 9 months postpartum in Burkina Faso
Official scientific title Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until 9 months postpartum in Burkina Faso and the Democratic Republic of Congo.
Brief summary describing the background and objectives of the trial The objective of this study is to identify a package of postpartum family planning interventions and determine its effect on the use of contraceptive methods during the first year postpartum. The research entails a complex intervention design with three study phases: a pre-formative phase, a formative phase and an intervention phase. These phases are interconnected and have their own objectives, methodologies and results. Given the complex nature of this intervention, we apply the recommendations from the Medical Research Council (2008) in the process of developing the intervention, determining its feasibility, implementation, and evaluation. The specific objective of the pre-formative phase is to establish a sampling frame of potential study sites by mapping primary health centers according to pre-established criteria (6 months) The specific objective of the formative phase is to identify through a participatory approach a PPFP intervention package to be implemented during the intervention phase (12 months) The specific objective of the intervention phase is to determine, through a cluster randomized controlled trial design, the effect of the PPFP intervention package on the uptake of contraceptive methods during the extended postpartum period, in comparison with the standard of care. The study concludes with qualitative research that is aimed at identifying operational reasons for success or failure in the implementation of PPFP services (18 months)
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Yam Daabo
Disease(s) or condition(s) being studied Postpartum family planning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 21/03/2016
Actual trial start date 27/07/2016
Anticipated date of last follow up 31/08/2016
Actual Last follow-up date 28/02/2018
Anticipated target sample size (number of participants) 560
Actual target sample size (number of participants) 1147
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
RPC757
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 randomization of study sites using a randomization table criteria. Health centers selected for the formative phase does not participate in the intervention phase. This is a cluster RCT Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization of study sites using a randomization table criteria. Health centers selected for the formative phase does not participate in the intervention phase. This is a cluster RCT Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Routine PPFP care As per usual care As per usual care PPFP information and services currently practiced in country 280 Active-Treatment of Control Group
Experimental Group PPFP intervention package From the 3rd trimester of pregnancy until the first year postpartum Up to 15 months Package of PPFP interventions as identified in the formative phase by community members, health staff and policymakers 280 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All pregnant women will be eligible to participate in the intervention phase of the study if (1) they are in their third pregnancy trimester; (2) the status of the pregnancy and of the woman allows for a birth at the health center; (3) the woman has the intention to attend ANC, delivery and PNC at the health center; (4) the woman does not participate in another study; and (5) an informed consent is obtained. All pregnant women that will not be eligible to participate in the intervention phase of the study if (1) they are not in their third pregnancy trimester; (2) the status of the pregnancy and of the woman do not allow for a birth at the health center; (3) the woman has not the intention to attend ANC, delivery and PNC at the health center; (4) the woman does participate in another study; and (5) an informed consent is not obtained. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 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 21/03/2016 Research Ethics Committe The World Health Organization
Ethics Committee Address
Street address City Postal code Country
Avenue Appia 20 Geneva 1211 Switzerland
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 03/02/2016 Comite dethique pour la recherche en sante Ministere de la recherche scientifique et de l innovation Ministere de la sante
Ethics Committee Address
Street address City Postal code Country
03 BP 7009 Building Lamizana Ouagadougou 1111 Burkina Faso
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 11/02/2016 Comite d ethique Ecole de sante publique Universite de Kinshasa
Ethics Committee Address
Street address City Postal code Country
BP 11850 Kinshasa 1111 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the uptake of a modern contraceptive method at nine months postpartum. Twelve months. We acknowledge the fact that a longer follow-up period up to 24 months is desirable
Secondary Outcome Intention to use a contraceptive method, and decision made to use a contraceptive method - 3rd trimester of pregnancy - 24-48 hours postpartum - 6 days postpartum - 6 weeks postpartum - 6 months postpartum - 12 months postpartum
Secondary Outcome Use of a modern contraceptive method - 24-48 hours postpartum - 6 days postpartum - 6 weeks postpartum - 6 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut de Recherche en Sciences de la Sante (IRSS) Ouagadougou Burkina Faso
School of Public Health / Ecole de Sante Publique, University of Kinshasa Kinshasa Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Government of France Paris Cedex 75732 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Reproductive Health Research, World Health Organization, Geneva, Switzerland Avenue Appia 20 Geneva 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CUZIN-KIHL Asa Avenue Appia 20 Geneva 1211 Switzerland
GAFFIELD Mary Lyn Avenue Appia 20 Geneva 1211 Switzerland
REIER Suzanne Avenue Appia 20 Geneva 1211 Switzerland
KIARIE James Avenue Appia 20 Geneva 1211 Switzerland
TRAN Nguyen Toan Avenue Appia 20 Geneva 1211 Switzerland
LANDOULSI Sihem Avenue Appia 20 Geneva 1211 Switzerland
SEUC Armando Avenue Appia 20 Geneva 1211 Switzerland
Yodi Rachel Kinshasa 02, Commune de Lemba Kinshasa Democratic Republic of the Congo
Thieba Blandine 03 BP 7192 Ouagadougou 03 Burkina Faso Ouagadougou BP 7192 Burkina Faso
Séni Kouanda (PI) 03 BP 7192 Ouagadougou 03 Burkina Faso Ouagadougou BP 1792 Burkina Faso
Désiré Mashinda (PI) Kinshasa 02, Commune de Lemba Kinshasa Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Lyn Gaffield, gaffieldm@who.int 0041227911806 Avenue Appia 20
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Technical Officer, World Health Organization
Role Name Email Phone Street address
Public Enquiries Mary Lyn Gaffield, gaffieldm@who.int 0041227911806 Avenue Appia 20
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Technical Officer, World Health Organization
Role Name Email Phone Street address
Scientific Enquiries Mary Lyn Gaffield gaffieldm@who.int 0041227911806 World Health Organization, 20 Avenue Appia
City Postal code Country Position/Affiliation
Geneva 1211 Switzerland Technical Officer, World Health Organization
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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
Trial Information Trial type 18/09/2016 Modified CCT RCT
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 Other disease 05/07/2018 pactr update Postpartum family planning (PPFP) Postpartum family planning
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 18/04/2019 edit Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until 9 months postpartum in Burkina Fas Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until 9 months postpartum in Burkina Faso
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 06/06/2019 update No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 06/06/2019 update No No
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2019 update TRUE, Research Ethics Committe, The World Health Organization, Avenue Appia 20, Geneva, 1211, Switzerland, , 21 Mar 2016, , , TRUE, Research Ethics Committe The World Health Organization, Avenue Appia 20, Geneva, 1211, Switzerland, , 21 Mar 2016, 000000000000, ct_ethics@who.int, 1784_1422_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2019 update TRUE, Comité d'éthique pour la recherche en santé, Ministère de la recherche scientifique et de l'innovation, Ministère de la santé, , Ouagadougou, , Burkina Faso, , 03 Feb 2016, , , TRUE, Comite dethique pour la recherche en sante Ministere de la recherche scientifique et de l innovation Ministere de la sante, 03 BP 7009 Building Lamizana, Ouagadougou, 1111, Burkina Faso, , 03 Feb 2016, 22650324159, bocar@fastnet.bf, 1784_1423_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2019 update TRUE, Comité d'éthique, Ecole de santé publique, Université de Kinshasa, BP 11850, Kinshasa, 1, Democratic Republic of the Congo, , 11 Feb 2016, , , TRUE, Comite d ethique Ecole de sante publique Universite de Kinshasa, BP 11850, Kinshasa, 1111, Democratic Republic of the Congo, , 11 Feb 2016, 243812227298, contact@unikin.ac.cd, 1784_1424_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 06/06/2019 updated information All pregnant women will be eligible to participate in the intervention phase of the study if (1) they are in their third pregnancy trimester; (2) the status of the pregnancy and of the woman allows for a birth at the health center; (3) the woman has the intention to attend ANC, delivery and PNC at the health center; (3) the woman does not participate in another study; and (4) an informed consent is obtained. All pregnant women will be eligible to participate in the intervention phase of the study if (1) they are in their third pregnancy trimester; (2) the status of the pregnancy and of the woman allows for a birth at the health center; (3) the woman has the intention to attend ANC, delivery and PNC at the health center; (4) the woman does not participate in another study; and (5) an informed consent is obtained.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 06/06/2019 updated information All pregnant women that will not be eligible to participate in the intervention phase of the study if (1) they are not in their third pregnancy trimester; (2) the status of the pregnancy and of the woman do not allow for a birth at the health center; (3) the woman has not the intention to attend ANC, delivery and PNC at the health center; (3) the woman does participate in another study; and (4) an informed consent is not obtained. All pregnant women that will not be eligible to participate in the intervention phase of the study if (1) they are not in their third pregnancy trimester; (2) the status of the pregnancy and of the woman do not allow for a birth at the health center; (3) the woman has not the intention to attend ANC, delivery and PNC at the health center; (4) the woman does participate in another study; and (5) an informed consent is not obtained.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 06/06/2019 update Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/06/2019 update 01 Jul 2016 27 Jul 2016
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 06/06/2019 update 17 Sep 2016 28 Feb 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 06/06/2019 571 in Burkina Faso and 576 in DRC 1147
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/06/2019 update Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 06/06/2019 updated information Primary Outcome, The primary outcome is the uptake of a modern contraceptive method at nine months postpartum., Nine months. We e acknowledge the fact that a longer follow-up period up to 12 or 24 months is desirable but current funding does not allow follow-up beyond nine months. Primary Outcome, The primary outcome is the uptake of a modern contraceptive method at nine months postpartum., Twelve months. We acknowledge the fact that a longer follow-up period up to 24 months is desirable
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 06/06/2019 update Secondary Outcome, Intention to use a contraceptive method, and decision made to use a contraceptive method, - 3rd trimester of pregnancy - 24-48 hours postpartum - 6 days postpartum - 6 weeks postpartum - 6 months postpartum - 9/12 months postpartum Secondary Outcome, Intention to use a contraceptive method, and decision made to use a contraceptive method, - 3rd trimester of pregnancy - 24-48 hours postpartum - 6 days postpartum - 6 weeks postpartum - 6 months postpartum - 12 months postpartum