Changes to trial information |
Section Name
|
Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Trial type |
18/09/2016 |
Modified |
CCT |
RCT |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Trial phase |
05/07/2018 |
pactr update |
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Not Applicable |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Other disease |
05/07/2018 |
pactr update |
Postpartum family planning (PPFP) |
Postpartum family planning |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Plan to share IPD |
06/06/2019 |
update |
|
No |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Reporting |
Results Available |
06/06/2019 |
update |
No |
No |
Section Name
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Field Name
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Date
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Reason
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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
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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Date
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Reason
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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
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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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
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Field Name
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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
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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
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Field Name
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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 |