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: pactr.samrc.ac.za
Trial no.: PACTR202109586388973 Date of Approval: 28/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of targeted antenatal family planning information provision on immediate postpartum family planning uptake in Kisumu County
Official scientific title Targeted Antenatal Information Provision and Postpartum Fertility Decisions
Brief summary describing the background and objectives of the trial The research team will utilize theory of planned behaviour in: assessing socio-cultural beliefs towards of Postpartum Family Planning (PPFP) and perceived individual control of postpartum fertility choice, analysing knowledge and fertility intention and finally compare and examine the determinants of PPFP uptake between study groups. A group of 246 antenatal mothers will be randomly assigned to control, community and facility intervention groups as per eligibility criteria in the study facilities that will be cluster sampled. After at least 6 months of intervention and 3 months of postpartum follow-up, clinical superiority will be used to gauge which invention was effective and the model with better results. Electronic Case Report Forms, client exit questionnaire and post intervention questionnaire will be used to collect data. Data analysis will in IBM’s SPSS version 21. The participant will form the unit of analysis and intra-cluster correlation coefficient will be accounted for and analysis will be by intention to treat.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) i decide
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2021
Actual trial start date
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 246
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Targeted Antenatal Family Planning Information Provision and appointment setting. At least once in the antenatal period for 6 months of intervention 6 months The trained study nurses in the study facility recruit the participants. Upon recruiting the intervention groups are taken through an intense research-protocol-standardized FP counselling session either by a nurse or by a community health worker. The participant is then allowed to decide whether she can set a postnatal appointment for uptake or follow-up. 164
Control Group None Routine MCH services None None None 82 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The Health centres are eligible if : i) They offer the continuum of ANC, delivery, and PNC; ii) They provide a selection of at least three modern contraceptive methods that are rated 2 or 1 on the Medical Eligibility Criteria (MEC) for Postpartum Contraceptives, including a barrier method such as condom, a short-term method such as pills, a long-term method such as intra-uterine device and referrals for permanent methods to clients; iii) There were no stock-outs of contraceptives during the preceding six months; iv) They have on average at least 10 deliveries per month; and v) They are willing to participate. All pregnant women will be eligible to participate in the study if: i) They are in their second pregnancy trimester; ii) The woman is attending ANC and has intention of attending PNC at the health centre; iii) An informed consent is obtained; iv) Resides within 20km Excluded from the study will be: i) Those that meet selection criteria but are participants in another study; ii) Latex sensitivity; iii) Not anticipating a male partner in the next 12 months; iv) Unable to complete consent form as determined by the study nurse or cha and v) The only male partner has had a vasectomy. Adult: 19 Year-44 Year 18 Year(s) 45 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 08/10/2021 Masinde Muliro University of Science and Technology
Ethics Committee Address
Street address City Postal code Country
PO Box 190 Kakamega 50100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nature of Fertility decisions postpartum. Primarily the uptake of immediate postpartum FP being the main outcome. 3 Months Postpartum. At 14 weeks MCH visit.
Secondary Outcome Fertility intentions. Primarily whether they accept to book an appointment for postpartum family planning Antenatal period after intervention
Secondary Outcome Knowledge of family planning methods Anytime after the intervention during the antenatal period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gita Health Center Kisumu East Sub-County MoH PO Box 150 Kisumu 40100 Kenya
Migosi Health Center Kisumu East Sub-County MoH PO Box 150 Kisumu 40100 Kenya
Nyalunya Health Center Kisumu East Sub-County MoH PO Box 150 Kisumu 40100 Kenya
Kuoyo Health Center Kisumu East Sub-County MoH PO Box 150 Kisumu 40100 Kenya
Chiga Health Center Kisumu East Sub-County MoH PO Box 150 Kisumu 40100 Kenya
Kowino Health Center Kisumu East Sub-County MoH PO Box 150 Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Morris S. Senghor PO Box 7299 Kisumu 40100 Kenya
County Government of Kisumu Department of Health PO Box 721 Kisumu 4010 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor County Government of Kisumu 721 Kisumu 40100 Kenya County Government
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Morris Senghor senghormorris@gmail.com +254720640142 PO Box 7299
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya PhD Student Masinde Muliro University
Role Name Email Phone Street address
Principal Investigator Gregory Ganda gregganda2@gmail.com +254726991098 PO Box 721
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Chief Officer of Health County Government of Kisumu
Role Name Email Phone Street address
Scientific Enquiries Collins Ouma couma@maseno.ac.ke +254722381214 Private Bag Maseno
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Professor of Biomedical Sciences Maseno University
Role Name Email Phone Street address
Public Enquiries Mary Kipmerewo kipmerewosoi@yahoo.com +254722797865 PO Box 190
City Postal code Country Position/Affiliation
Kakamega 50100 Kenya Senior Lecturer School of Nursing Masinde Muliro University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A link to published manuscripts will be shared with PACTR Informed Consent Form 2023 September Type of Access: Controlled Access, Type of analysis: Quantitative analysis Process of Requesting for Data: Request to be done by email of the principal investigator The decision is by the Research team lead by the Principal investigator Criteria for reviewing the request: Qualification of the person requesting, description of the purpose of the request, willingness to engage the Principal investigator in the development of analysis plan, and monographs or manuscripts.
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