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.: PACTR201710002636253 Date of Approval: 20/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Feasibility, acceptability and effectiveness of couple antenatal education in Blantyre, Malawi
Official scientific title Feasibility, acceptability and effectiveness of couple antenatal education in Blantyre, Malawi
Brief summary describing the background and objectives of the trial Despite men being recognized as partners in reducing maternal mortality, their involvement in maternal health including antenatal education remains low. Numerous factors have been reported as barriers related to male partner involvement some of which include lack of knowledge and the female design of maternal health services in general. Making maternal health services including antenatal education sessions male friendly may improve male partner¿s participation ultimately improving maternal health outcomes such as birth preparedness and knowledge on danger signs. However, there are limited rigorously conducted studies that have assessed the feasibility and effectiveness of male partner involvement in antenatal education. Additionally, the few studies have reported contradictory findings warranting for more interventional research which would help in understanding the significance of male partner involvement in antenatal education. The purpose of this study is to assess the feasibility and effectiveness of couple antenatal education by comparing the proportion of women prepared for birth and have knowledge on danger signs following receipt of two antenatal education sessions in the intervention and standard of care study arms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Not applicable
Disease(s) or condition(s) being studied Maternal health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 23/01/2017
Actual trial start date 06/02/2017
Anticipated date of last follow up 20/02/2018
Actual Last follow-up date 01/02/2018
Anticipated target sample size (number of participants) 485
Actual target sample size (number of participants) 485
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
College of Medicine Research and Ethics Committee (COMREC) Certificate No.P.11/151821
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation with variable block sizes(2, 4, 6 and 8) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Husband and wife Husband and wife receive antenatal education together as a couple 241
Control Group Wife only (Standard of Care) Wife receive antenatal education without the husband 244
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Women who will be pregnant and are 16 to 24 weeks gestation at booking. ¿ Women who have husbands and are living together. ¿ Women whose husbands are willing to be involved in antenatal education and are willing to come for antenatal couple education. ¿ Women who are willing to respond to the structured questionnaire at the beginning and finalization of the study. ¿ Women and husbands who are more than 18 years and are coming from the catchment area of the clinics. ¿ Women whose pregnancy is beyond 24 weeks. ¿ Women in polygamous relationship. ¿ Women who are single or married but do not stay with the male partner ¿ Women and husbands whose age is below 18 years. ¿ Women and men who received antenatal education not as husband and wife or those who received less than two couple antenatal education sessions. 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 21/01/2016 College of Medicine Research and Ethics Committee (COMREC)
Ethics Committee Address
Street address City Postal code Country
Mahtma Gandhi Blantyre Private Bag 360 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women prepared for birth After receiving two sessions of antenatal education End line survey at 34 to 36 weeks gestation
Secondary Outcome Knowledge score on danger signs during pregnancy, labour and delivery and postpartum period. A woman will be considered knowledgeable if she mentions one obstetric danger sign during each of the period of maternity cycle (pregnancy, labour and delivery and postpartum period). After receiving two sessions of antenatal education End line survey at 34 to 36 weeks gestation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mpemba health centre P.O Box 67 Chipatala Avenue Blantyre Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Consortioum for Advanced Research Training in Africa (CARTA) P.O BOX10787 NAIROBI 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Malawi, College of Medicine, Malawi Private Bag 360 Blantyre Malawi University
COLLABORATORS
Name Street address City Postal code Country
University of Malawi, Kamuzu College of Nursing P.O Box, 451 Blantyre Malawi
University of Malawi, Kamuzu College of Nursing P.O Box, 415 Blantyre Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maria Chikalipo mchikalipo@cartafrica.org +265 888309781 Mahatma Ghandhi Street
City Postal code Country Position/Affiliation
Blantyre Private Bag 360 Malawi PhD student
Role Name Email Phone Street address
Public Enquiries Yohannie Mlombe comrecchair@medcol.mw +265994969108/+265 01871911 Mahatma Ghandhi Street
City Postal code Country Position/Affiliation
Blantyre Private Bag, 360 Malawi College of Medicine Ethics Committee Chairperson
Role Name Email Phone Street address
Scientific Enquiries Adamson Muula amuula@medcol.mw 265 01-874-377 Private Bag 360
City Postal code Country Position/Affiliation
Blantyre Malawi Primary supervisor
Role Name Email Phone Street address
Scientific Enquiries Adamson Muula amuula@medcol.mw +265 01-874-377 Mahatma Ghandhi Street
City Postal code Country Position/Affiliation
Blantyre Private Bag 360 Malawi Primary supervisor
REPORTING
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Result URL Hyperlinks
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