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.: PACTR201801002864315 Date of Approval: 12/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Birth canal dilator study
Official scientific title Perineal dilator for delivery: a randomized trial
Brief summary describing the background and objectives of the trial During a woman¿s first birth, considerable stretching of the vaginal and perineal soft tissues takes place during the second stage of labour. This process may have several adverse effects such as delayed second stage and pelvic floor damage. These effects might be overcome by gentle stretching of the perineal muscles prior to the first birth. Two randomized trials have shown improved perineal outcomes following use of an inflatable perineal dilator during pregnancy. We will investigate the effects of using a perineal dilator during the first stage of labour.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied labour, delivery,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/07/2017
Actual trial start date
Anticipated date of last follow up 29/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 206
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
M170624 University of the Witwatersrand HREC
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 Computer-generated random sequence in variable balanced blocks of 4-8 Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Computer-generated random sequence in variable balanced blocks of 4-8 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of perineal dilator Single use during first stage of labour Until full dilation achieved (about 40 minutes Balloon perineal dilator introduced to vagina and slowly inflated till full dilation achieved, left for 10 minutes, then removed 103
Control Group Routine care Routine care Routine care No dilator used - routine care 103
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Nulliparous women Aged 18 years or above No major complications of pregnancy In active labour Vaginal birth anticipated Consent given Any contra-indication to use of dilator 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 28/07/2017 University of the Witwatersrand HREC
Ethics Committee Address
Street address City Postal code Country
York Rd, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Spontaneous delivery within 15 minutes of bearing down Commencement of bearing down Complete birth of baby
Secondary Outcome Assisted delivery At delivery
Secondary Outcome Caesarean section At delivery
Secondary Outcome Episiotomy At delivery
Secondary Outcome Perineal tears At delivery
Secondary Outcome Number of perineal sutures After delivery
Secondary Outcome Apgar score 5 minutes after birth
Secondary Outcome Arterial cord blood pH or lactate After delivery
Secondary Outcome Maternal satisfaction Postpartum
Secondary Outcome Urinary incontinence 3 months after birth
Secondary Outcome Flatus incontinence 3 months after birth
Secondary Outcome Faeces incontinence 3 months after birth
Secondary Outcome Perineal pain 3 months after birth
Secondary Outcome Dyspareunia 3 months after birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cecilia Makiwane Hospital 4 Billie Rd Mdantsane 5219 South Africa
Frere Hospital Amalinda Drive East London 5201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of the Witwatersrand York Rd, Parktown Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Effective Care Research Unit, University of Witwatersrand and Fort Hare Amalinda Drive East London 5201 South Africa University
COLLABORATORS
Name Street address City Postal code Country
GJ Hofmeyr Amalinda Drive East London 5201 South Africa
M Singata-Madliki Amalinda Drive East London 5201 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator G Justus Hofmeyr justhof@gmail.com 0832809402 Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director
Role Name Email Phone Street address
Public Enquiries G Justus Hofmeyr justhof@gmail.com 0832809402 Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director
Role Name Email Phone Street address
Scientific Enquiries G Justus Hofmeyr justhof@gmail.com 0832809402 Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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