|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201710002636253 |
|
Date of registration:
|
20/09/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Feasibility, acceptability and effectiveness of couple antenatal education in Blantyre, Malawi
|
|
Scientific title:
|
Feasibility, acceptability and effectiveness of couple antenatal education in Blantyre, Malawi |
|
Date of first enrolment:
|
23/01/2017 |
|
Target sample size:
|
485 |
|
Recruitment status: |
Other |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2636 |
|
Study type:
|
Interventional |
|
Study design:
|
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
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Malawi
| | | | | | | |
|
Contacts
|
|
Name:
|
Yohannie
Mlombe |
|
Address:
|
Mahatma Ghandhi Street
Private Bag, 360
Blantyre
Malawi |
|
Telephone:
|
+265994969108/+265 01871911 |
|
Email:
|
comrecchair@medcol.mw |
|
Affiliation:
|
College of Medicine Ethics Committee Chairperson |
|
|
Name:
|
Adamson
Muula |
|
Address:
|
Private Bag 360
Blantyre
Malawi |
|
Telephone:
|
265 01-874-377 |
|
Email:
|
amuula@medcol.mw |
|
Affiliation:
|
Primary supervisor |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: ¿ 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.
Exclusion criteria: ¿ 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.
Age minimum:
18 Year(s)
Age maximum:
45 Year(s)
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Maternal health
|
Maternal health
|
|
Intervention(s)
|
|
Husband and wife
|
|
|
|
Wife only (Standard of Care)
|
|
Primary Outcome(s)
|
|
Proportion of women prepared for birth
|
|
Secondary Outcome(s)
|
|
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).
|
|
Secondary ID(s)
|
|
College of Medicine Research and Ethics Committee (COMREC) Certificate No.P.11/151821
|
|
Source(s) of Monetary Support
|
|
Consortioum for Advanced Research Training in Africa (CARTA)
|
|
Ethics review
|
Status: Approved
Approval date: 21/01/2016
Contact:
College of Medicine Research and Ethics Committee (COMREC)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|