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.: PACTR202205822672935 Date of Approval: 04/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of multiple versus once-only membrane sweeping at term in preventing prolonged pregnancy: a randomised controlled trial
Official scientific title Effectiveness of multiple versus once-only membrane sweeping at term in preventing prolonged pregnancy: a randomised controlled trial
Brief summary describing the background and objectives of the trial Background: Between 4 – 18% of pregnancies are prolonged. Prolonged pregnancy is associated with adverse maternal and perinatal outcomes. Objectives: To compare the effectiveness of once-only versus multiple (weekly) membrane sweeping in reducing the incidence of prolonged pregnancy. Materials and Methods: This randomised controlled trial was conducted over a two-year period, from January, 2018 – December, 2020, at the Federal Medical Centre and Diete-Koki Memorial Hospital, both in Yenagoa, Bayelsa State, Nigeria. Seven hundred and eighty-six women were equally randomized into two groups: once-only and multiple membrane sweeping, initiated at 39 weeks’ gestational age, but 742 women were included in the analysis. Data obtained was analysed using the Statistical Package for Service Solutions for Windows® version 20, SPSS Inc.; Chicago, USA). Associations between categorical independent and outcome variables were assessed, where applicable, using Chi square test at 95% confidence interval. A P-value of <0.05 was considered statistically significant.
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 Prevention of prolonged pregnancy
Purpose of the trial Prevention
Anticipated trial start date 03/01/2017
Actual trial start date 02/01/2019
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 786
Actual target sample size (number of participants) 742
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A Once-only membrane sweeping Once Women who met the inclusion criteria and consented to participate in the study were equally randomized (1:1 ratio) into two groups: A for once-only membrane sweeping and B for multiple (weekly) membrane sweeping. Those allocated to group A, had their foetal membranes swept only once at 39 weeks’ gestational age, All women in both groups who did not go into spontaneous labour by 41 weeks and 3 days’ gestational age, were admitted and had cervical ripening and induction of labour according to the hospitals’ protocols. 371 Active-Treatment of Control Group
Experimental Group Group B Multiple (weekly) membrane sweeping Once weekly Women who met the inclusion criteria and consented to participate in the study were equally randomized (1:1 ratio) into two groups: A for once-only membrane sweeping and B for multiple (weekly) membrane sweeping. Those allocated to group B had their foetal membranes swept once-weekly beginning from 39 weeks’ gestational age. All women in both groups who did not go into spontaneous labour by 41 weeks and 3 days’ gestational age, were admitted and had cervical ripening and induction of labour according to the hospitals’ protocols. 371
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting booked patients receiving antenatal care at the Federal Medical Centre and Diete-Koki Memorial Hospital, both in Yenagoa, at 39 weeks’ gestational age (reliably confirmed by last menstrual period or/and early ultrasound scan), with a singleton foetus, in cephalic presentation and longitudinal lie, with intact foetal membranes, and no contraindication to vaginal delivery. Patients with a contraindication to vaginal delivery, abnormal foetal lie and malpresentation, previous Caesarean section, patients being planned for trial of labour after a previous Caesarean section, Human Immunodeficiency Virus, Hepatitis B and C virus infections, were excluded from the study. Adult: 19 Year-44 Year 15 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 25/10/2016 Research Ethics Committee Federal Medical Centre Yenagoa
Ethics Committee Address
Street address City Postal code Country
1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was the proportion of pregnant women whose pregnancies extended to 41 weeks and 3 days’ gestational age in both groups, thus requiring labour induction. During and after the procedure
Secondary Outcome The secondary outcome measures include the incidence rate of pre-labour rupture of membranes, meconium-stained amniotic fluid, foetal Apgar scores at one and five minutes, Caesarean section rate, maternal pain, maternal satisfaction and acceptability. During and after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Yenagoa 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
Diete Koki Memorial Hospital Hospital Road, Opolo, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Chidiebere Njoku 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Chidiebere Njoku 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria Yenagoa 560001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Chidiebere Njoku nic2u4u@yahoo.com +2348067502398 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Principal Investigator Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Public Enquiries Peter Chibuzor Oriji chibuzor54@gmail.com +2348030677372 1, Hospital Road, Ovom, Yenagoa, Bayelsa State, Nigeria
City Postal code Country Position/Affiliation
Yenagoa 560001 Nigeria Consultant Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The participants' data will be available in the results after data analysis. The study protocol and participants' data that underlie the results reported in this article (text, table, figures and appendices), will be available after de-identification. Data will be available immediately after publication. There will be no end date. Data will be available to anyone who wishes to access it, for any purpose, and indefinitely. There will be no restrictions. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately after publication. There will be no end date. Data will be available to anyone who wishes to access it, for any purpose, and indefinitely. There will be no restrictions.
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