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.: PACTR202108520442195 Date of Approval: 30/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Family Planning Interventions on Maternal and Infant Mortality in Two Cameroon Development Corporation Plantation Camps
Official scientific title Impact of Family Planning Interventions on Maternal and Infant Mortality in Two Cameroon Development Corporation Plantation Camps
Brief summary describing the background and objectives of the trial The Maternal mortality rate in Cameroon has risen by 8% from 680 to 872 deaths per 100000 in the past 9 years after an initial decrease. An unpublished data source from the SW Regional Delegation has revealed a high proportion of unfavourable pregnancy outcomes in the region in the past 2 years. The Tiko Health District has registered the second highest maternal deaths in the region. There is sufficient evidence that by reducing the number of high risk pregnancy, the large scale use of family planning can reduce maternal and infant mortality. However, studies in Cameroon show that a large proportion of women of reproductive age do not use family planning and those who desire family planning services for one reason or another have not yet had access to them even in large cities like Douala and Yaoundé where there is presumably greater access to family planning services. Lack of information and misconception on family planning continues to remain major barriers to family planning uptake. Our study seeks to assess the impact of family planning intervention on maternal and infant mortality in the Tiko CDC plantation camps. Specifically, we will i) asses the knowledge on family planning in the Tiko CDC plantation camps ii) assess the attitude of family planning in the Tiko CDC plantation camps iii) assess the practice of family planning in the Tiko CDC plantation camps iv) determine the barriers to family planning uptake in the Tiko CDC plantation camps v) evaluate the impact of family planning interventions on the perception of family planning in the Tiko CDC plantation camps vi) evaluate the impact of the family planning interventions on the maternal mortality vii) evaluate the impact of the family planning interventions on the infant mortality in the Tiko CDC plantation camp
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Family planning
Purpose of the trial Education /Training
Anticipated trial start date 02/03/2020
Actual trial start date 02/03/2021
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 500
Recruitment status Completed
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 Non-randomised 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 Family planning distribution and health education The intervention was active throughout the intervention time (i.e. from 02/03/2020 to 31/03/2021). This intervention was a triad of health education on family planning, health facilities strengthening on reproductive health services and community distribution of contraceptive methods to those in need and with appropriate indication. 12 month Step 1: Selection and training of data collectors for the study Eight (8) community health workers (CHW) were selected (4 for Tiko and 4 for Penda Mboko CDC plantation camps) to guide the data collectors throughout the study as they access the community. Step 2: Collection of Baseline Data in the intervention and control site Data related to socio-demographic and reproductive life of the participants were collected from 333 sampled participants in the intervention site from December 2019 to February 2020. Step 3: Health facilities strengthening on family planning services Cottage hospital and PMI in Tiko town were the two main recognized health facilities offering family planning services to the Tiko population including the Tiko CDC plantation camp residents. Two family planning personnel from each of these facilities were interviewed concerning family planning service deliveries Step 4: Family planning health education The information content of the health education intervention was contextually tailored to handle issues related to the importance and advantages of family planning and different methods, poor knowledge, misconceptions, misuse, barriers to use including availability and accessibility problems. Step 5: Increasing family planning availability and accessibility This was achieved through free reproductive health consultation and distribution of male condoms, female condoms and oral contraceptive pill in the intervention community. Step 6: Monitoring and evaluation The trained family planning providers of the cottage hospital and PMI have been charged with monitoring and evaluation of family planning service delivery in these facilities and are required to provide report on monthly basis. 250
Control Group None 12 Months No intervention will be done for the control group 250 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Women of age group 15-49 years in or intend to start a relationship • Men in relationship with a woman • Must be resident within the camps • Women of age below 15 and above 49 years • Reside outside the camp Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 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 12/12/2019 The Institutional Ethics Committee for Research on Human Health of the University of Douala
Ethics Committee Address
Street address City Postal code Country
Campus de Logbessou Douala Douala 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge, attitude, practice and barriers to family planning uptake in Tiko CDC plantation camp 12 months from onset of the intervention
Secondary Outcome Maternal and infant mortality in the Tiko CDC plantation camp 12 months from onset of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tiko and Penda mboko CDC plantation camps CDC plantation camps Tiko and Penda Mboko 00237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Emeh Nathan Agbor PK 17, Chief entrance Douala 00237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Buea Molyko-Buea Buea 00237 Cameroon University
COLLABORATORS
Name Street address City Postal code Country
Alpha Higher Institude Douala Deido-Douala Douala 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Agbor Nathan Emeh emehnathan@yahoo.com 00237677392578 Melong District Hospital
City Postal code Country Position/Affiliation
Melong Centre 00237 Cameroon Medical researcher at University of Buea
Role Name Email Phone Street address
Public Enquiries Ngouakam Hermann tiingou4@yahoo.com 00237670395424 Molyko-Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Researcher at University of Buea
Role Name Email Phone Street address
Scientific Enquiries Nsagha Dickson Shey nsaghads@hotmail.com 00237677499429 Molyko-Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Researcher at University of Buea
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We attest that summary results of this intervention study will be made available to the general public open access through publication in appropriate journals and on the registry website. Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months It will be open access. However, full reference should by made to the study investigators when the data is used. Request should be made to the principal investigator through the email: emehnathan@yahoo.com
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