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.: PACTR202112841108933 Date of Approval: 22/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness and safety of membrane sweeping in preventing post term pregnancy
Official scientific title A randomized controlled trial evaluating the frequency, safety and effectiveness of membrane sweeping in the prevention of post term pregnancy among low risk parturients in Federal Medical Centre Lokoja, Kogi State
Brief summary describing the background and objectives of the trial There is a rising concern with increasing rates of pharmacologically induced labour and it's complications. Membrane sweeping is a simple,cost effective and less invasive means of preventing prolonged pregnancy and reducing the complications associated with labour induction. The study intends to determine and compare the frequency,safety and effectiveness of membrane sweeping among the control, once weekly and twice weekly groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 08/06/2020
Actual trial start date 08/06/2020
Anticipated date of last follow up 09/06/2021
Actual Last follow-up date 08/06/2021
Anticipated target sample size (number of participants) 186
Actual target sample size (number of participants) 184
Recruitment status Completed
Publication 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Once weekly membrane sweeping group B Had membrane sweeping once in a week at every antenatal visit From 39weeks till 41weeks 3days(3weeks) Membrane sweeping carried out once in a week for eligible participants from 39weeks,once in a week till spontaneous labour commences or till 41weeks 3days when procedure terminated 62
Experimental Group Twice weekly membrane group C Had membrane sweeping twice in a week, at least 72hours apart From 39weeks till spontaneous labour onset or till 41weeks 3days when labour is induced Membrane sweeping was carried out from 39weeks on the antenatal day and 72hours thereafter, thus twice in a week till spontaneous onset of labour or 41weeks 3days when labour is induced 60
Control Group Control group A No membrane sweeping done. Participants just monitored till delivery without any interventions Normal antenatal care was offered from recruitment till delivery 62 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting low risk pregnant women at 39weeks in the antenatal clinic who are planned for vaginal delivery Hypertensive disorders in pregnancy Sickle cell disease in pregnancy Cardiac disease in pregnancy Active vagina infections Multiple pregnancy Coagulation abnormalities Antepartum Haemorrhage Contraindications to vagina delivery Adult: 19 Year-44 Year 15 Year(s) 50 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 08/06/2020 FMCL Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
No 1,Salihu Ibrahim road, Federal Medical Centre Lokoja Kogi State Lokoja 1001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of women who are undelivered at 41weeks 3days and needed induction of labour At 41weeks 3days in labour ward
Secondary Outcome Gestational age at delivery At delivery in labour ward
Secondary Outcome Interval between recruitment and labour onset in days During labour
Secondary Outcome Need for oxytocin use in labour Labour
Secondary Outcome Prelabour rupture of membrane Labour
Secondary Outcome Vagina bleeding Labour
Secondary Outcome Chorioamnionitis Labour
Secondary Outcome Apgar scores at 1&5miniutes and SCBU admission Post delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Lokoja PMB 1001, No 1, Salihu Ibrahim road, Lokoja, Kogi State Lokoja 1001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Salau Olaide Department of Obstetrics and Gynaecology PMB 1001 FMC Lokoja Kogi State Lokoja 1001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Salau Jelili Olaide Department of Obstetrics and gynaecology, PMB 1001, FMC Lokoja Lokoja 1001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Salau Olaide salauolaide7@gmail.com +2347064195005 Dept of Obstetrics and gynaecology, FMC Lokoja
City Postal code Country Position/Affiliation
Lokoja 1001 Nigeria Consultant Gynaecologist
Role Name Email Phone Street address
Scientific Enquiries Salau Olaide salauolaide7@gmail.com +2347064195005 Dept of Obstetrics and gynaecology, FMC Lokoja
City Postal code Country Position/Affiliation
Lokoja 1001 Nigeria Consultant Gynaecologist
Role Name Email Phone Street address
Public Enquiries Salau Olaide salauolaide7@gmail.com +2347064195005 Dept of Obstetrics and gynaecology FMC Lokoja
City Postal code Country Position/Affiliation
Lokoja 1001 Nigeria Consultant Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data will be available. All of the individual participants data collected during the trial after deidentification will be shared. Study protocol will be made available. Data will be available immediately following publication to any researcher or investigator for scientific purpose. Study Protocol IPD will be available immediately following publication It will be accessible to any research or investigator purely for scientific basis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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