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.: PACTR202105826145332 Date of Approval: 20/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Early Resumption of Sexual Intercourse in the Puerperium Among Mothers in Uganda: Burden and the Effect of Health Education on Puerperal Abstinence
Official scientific title Early Resumption of Sexual Intercourse in the Puerperium Among Mothers in Uganda: Burden and the Effect of Health Education on Puerperal Abstinence
Brief summary describing the background and objectives of the trial Research done globally and in Uganda indicates that despite guidance from the World Health Organization, the early resumption of sexual intercourse in the puerperium (ERSP), remains high. To address this problem, the study aims to obtain an in-depth understanding of ERSP among new mothers, their partners, and health workers; and to design and test a psycho-sexual educational intervention that will delay ERSP. To gather data, a mixed- methods approach will be employed. The quantitative approach will use a survey among mothers in the post natal clinic, while the qualitative approach will comprise four sub studies. The first qualitative substudy will involve conducting in depth interviews (IDI) with women in the Post Natal clinic; the second qualitative sub study will involve conducting focus group discussions (FGD) with with men in the Antenatal clinics; the third qualitative sub study will involve conducting FGDs with women in the both the Antenatal and Post natal clinics; the fourth qualitative sub study will involve conducting Key Informant Interviews (KII) with the health care workers. The IDIs will employ the Narrative Inquiry research tradition, while the FGD and the Key informant interviews will employ the constant comparison and classical content analysis. After that, findings from the survey and the qualitative studies will be triangulated to design and test a psycho-sexual educational intervention that will delay the early resumption of sexual intercourse in the puerperium.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Early Resumption of Sexual Intercourse in the Puerperium among new mothers
Purpose of the trial Prevention
Anticipated trial start date 01/08/2021
Actual trial start date 31/08/2021
Anticipated date of last follow up 16/01/2022
Actual Last follow-up date 28/02/2022
Anticipated target sample size (number of participants) 356
Actual target sample size (number of participants) 356
Recruitment status Not yet recruiting
Publication URL 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 Permuted block randomization Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Education A pre-designed psycho-sexual specialized counselling and education session on postpartum sexual health at 32 weeks of gestation, immediatly following birth, thereafter weekly for a period of six weeks during puerperium 8 weeks Participants in the intervention arm will receive a pre-designed psycho-sexual specialized counselling and education on postpartum sexual health at 32 weeks of gestation. The content of the intervention will include: the physiology of sexual activity as described by Basson Rosemary, the physiological changes after delivery, psychological aspects and sexual aspects of sexual relations after childbirth, and post-partum sexual abstinence. After the first session, a pamphlet and hand outs will be given to the participant in the intervention arm. After delivery, mothers will be followed weekly on phone for a five minute counselling session reminding them to practice sexual abstinence, and to review the previous educational material. The specialized counselling and education will be conducted by the midwives who will be trained in puerperal psycho-sexual health. A physical exam of the perineum to examine for tears, bruises, and infections during the routine postpartum visits will be conducted during the routine visits. The primary outcome measure is reduction the early resumption of puerperal sexual intercourse measured as binary outcome. The secondary outcome is time to resumption of sex expressed as survival analysis. 178
Control Group Standard post partum care Not applicable 8 weeks The participants in the control arm will receive standard postnatal care information and checkups at seven days, and thereafter, reminders toattend the six weeks post partum review so that the participants in the control arm adhere to their postnatal check 178 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
≥ 32 weeks married/ cohabiting, monogamous relationships 18 years and above the couple must have phones should give consent should live with the spouse during puerperium. Evidence of Gender-Based Violence mentally sick member of the couple morbidity relating to the pregnancy such as Diabetes, Eclampsia Male partner refuses participation Persons at higher risk of severe illness from COVID-19 Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Both
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 14/09/2020 Mengo Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
169 Sir Albert Cook Rd Kampala 0256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is reduction the early resumption of puerperal sexual intercourse measured as binary outcome. 6 weeks following childbirth
Secondary Outcome The secondary outcome is time to resumption of sex expressed as survival analysis. six weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mengo Hospital 169 Sir Albert Cook Road Kampala 0256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Edith Namulema 169 Sir Albert Cook Road Kampala 0256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Edith Namulema 169 Sir Albert Cook Road Kampala 056 Uganda SELF Sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edith Namulema edith.namulema@mengohospital.org 0256772460792 169 Sir Albert Cook Road
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Medical Doctor
Role Name Email Phone Street address
Public Enquiries Micheal Kawooya kawooyagm@yahoo.co.uk 25677250589 169 Sir Albert Cook Road Mengo
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Chairperson REC
Role Name Email Phone Street address
Scientific Enquiries Sarah Nakubulwa sarahug@gmail.com 256772443416 Makerere University
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial after de-identification will be shared. The study protocol, statistical analysis plan, analytical codes and the informed consent will be available for review. Data will be made available 12 months following publication by the student. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD and Results available on request from the Principal investigator at 12 months following publication of results Euclid University, International Faculty Coordinator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL 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