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.: PACTR201407000834391 Date of Approval: 22/05/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF PELVIC FLOOR MUSCLE TRAINING AMONG PREGNANT BLACK AFRICAN POPULATION ON THE RISK OF POSPARTUM URINARY INCONTINENCE, A SINGLE BLIND RANDOMIZE
Official scientific title EFFECT OF PELVIC FLOOR MUSCLE TRAINING AMONG PREGNANT BLACK AFRICAN POPULATION ON THE RISK OF POSPARTUM URINARY INCONTINENCE, A SINGLE BLIND RANDOMIZED CONTROL TRIAL
Brief summary describing the background and objectives of the trial ABSTRACT BACKGROUND Pelvic Floor Muscle Training (PFMT) in the antenatal period has been found to be an effective primary prevention intervention in the Caucasian population in reducing the incidence of postpartum Urinary Incontinence. OBJECTIVE This study is primarily designed to determine the effect of PFMT introduced in the second trimester amongst pregnant African population on the incidence of six weeks postpartum Urinary Incontinence. Secondary objectives include investigating the incidence of postpartum Urinary Incontinence, the effect of mode of delivery on incidence of postpartum Urinary Incontinence and determining contributory factors in this population on the incidence of postpartum Urinary Incontinence. STUDY DESIGN The study will be a single blind Randomized Control Trial. INTERVENTION PFMT to be conducted by a Physiotherapist and a Continence Nurse from recruitment to 37 completed weeks of gestation, with the control group receiving standard Antenatal care. ASSESSMENT OF URINARY INCONTINENCE STATUS Data collection will be done primarily by administering a validated questionnaire (ICIQ-UI Short Form) at recruitment in the Antenatal clinic and in the postpartum period at the six week postnatal visit. DATA ANALYSIS Intention to treat analysis will be undertaken using the SPSS Statistics 17.0 software package. The incidence of the 6 week postpartum Urinary Incontinence as a proportion for the treatment and control groups will be determined. Comparison of proportions will be done using the Chi-square test. P¿ 0.05 will be considered statistically significant.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied POSPARTUM URINARY INCONTINENCE,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/08/2014
Actual trial start date
Anticipated date of last follow up 27/03/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
2014/REC-25 RESEARCH SUPPORT UNIT, AGA KHAN UNIVERSITY
2014/REC-25 RESEARCH SUPPORT UNIT, AGA KHAN UNIVERSITY
2014/REC-25 RESEARCH SUPPORT UNIT, AGA KHAN UNIVERSITY
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
Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pelvic Floor Muscle Training three sets of 10 contractions with holding periods of 10 seconds (in sitting, kneeling or standing positions) per day. This regimen is to be repeated up to three times in a week 14 to 24 weeks The selected participants will be trained by a physiotherapist. Participants will be trained on how to identify Pelvic Floor Muscle contractions with instructions to pass a stream of urine with a full bladder then abruptly stop the flow of urine (inward lift and squeeze around the urethra, vagina and rectum). 33
Control Group Std Antenatal care Standard care 14 to 24 weeks Standard antenatal care 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Black African descent 18 years and above as determined by age of birth Primiparous with a singleton foetus Between 14-24 weeks of pregnancy as determined by a first trimester ultrasound scan. Pre-existing urinary incontinence of any type Severe medical illness requiring recurrent hospital admissions, or affect compliance with training regimen Obstetrical conditions likely to lead to preterm delivery, for example, severe Preeclampsia and Preterm Prolonged Rupture of Membranes History suggestive of neurological conditions, for example, myasthenia gravis History suggestive of collagen disorders, for example, Ehlers-Danlos Syndrome Diabetes Mellitus but not Gestational Diabetes Mellitus 18 Year(s) 49 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 11/08/2014 Ethics Committee, Aga Khan University, East Africa
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue, Off Limuru Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome An estimate of the risk of 6 week postpartum Urinary Incontinence as a proportion for the treatment and control groups. 6 weeks postpartum
Secondary Outcome Contributory factors in this population on the risk of postpartum Urinary Incontinence with specific reference to: a) Pre-pregnancy smoking b) BMI at ANC booking to be a surrogate for eliciting presence of pre-pregnancy obesity c) Age d) Cultural PFMT practices 6 weeks postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital, Nairobi 3rd Parklands Avenue, Off Limuru Road Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University, East Africa 3rd Parklands Avenue, Off Limuru Road, Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University, East Africa 3rd Parklands Avenue, Off Limuru Road, Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Antenatal Clinic, Aga Khan University Hospital, Nairobi 3rd Parklands Avenue, Off Limuru Road, Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samuel Ngugi samuel.ngugi@aku.edu 254722591677 3rd Parklands Avenue, Off Limuru Road,
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Resident
Role Name Email Phone Street address
Public Enquiries Ciru Kamanda kamanda.ciru@aku.edu +254 711 09 2148 3rd Parklands Avenue, Off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Research Support Unit
Role Name Email Phone Street address
Scientific Enquiries Johnstone Miheso johnstone.miheso@aku.edu +254 711 09 2186/2179 3rd Parklands Avenue, Off Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Study Supervisor
REPORTING
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