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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609818958466 Date of Registration: 10/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Once-only membrane sweeping at full-term for preventing prolonged pregnancy in multiparous women with one previous caesarean section: A double-blind randomised controlled trial at NAUTH, Nnewi, Nigeria.
Official scientific title Once-only membrane sweeping at full-term for preventing prolonged pregnancy in multiparous women with one previous caesarean section: A double-blind randomised controlled trial at NAUTH, Nnewi, Nigeria.
Brief summary describing the background and objectives of the trial Prolonged pregnancy has been a source of serious concern to expectant mothers, health-care providers and the society. When it occurs in a multiparous woman with one previous caesarean section, the worries become more palpable. This condition and its management are associated with some challenges that may result maternal and/or perinatal morbidity and/or mortality. Any modality that prevents prolonged pregnancy in this group of women will be a welcome development. Membrane sweeping seems a likely option that may bridge this gap and may have some effects Membrane sweeping may help to prevent prolonged pregnancy and shorten duration of pregnancy by promoting spontaneous onset of labour that will facilitate vaginal delivery in a parturient with one previous scar. This may help to eliminate the need for a repeat caesarean section and may also improve the Apgar score of neonates. Recent studies revealed that majority of women on weekly membrane sweeping deliver with the first sweep. Most women prefer once-only membrane sweeping (because it is not repeated) to weekly sweeping. Some studies showed that the outcomes from weekly sweeping is not superior to that from once-only sweeping. Sweeping has been found useful in low-risk pregnancies. The usefulness, timing and frequency of membrane sweeping in pregnant women with one previous caesarean section has been a controversial issue. There is no formal protocol on membrane sweeping at the study center, Thus, the need for this study of a once-only membrane sweeping at full term for preventing prolonged pregnancy in multiparous women with one previous caesarean section which is a double blind randomise control study at NAUTH, Nnewi. Anambra state, South-East, Nigeria. The objective is aimed at assessing the effect of a once-only membrane sweeping at full term for preventing prolonged pregnancy in multiparous women with one previous caesarean section
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 30/09/2026
Actual trial start date
Anticipated date of last follow up 31/03/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Experimental Group Membrane sweeping ONLY ONCE ONE MINUTE The participant will empty her urinary bladder and lie comfortably in dorsal position on the examination couch at the examining room of the antenatal clinic. The principal investigator washes his hands with soap and water and wears sterile surgical gloves on both hands. The participant’s vulva will be swabbed with 3 gauze soaked in salon. The vulva is parted with less dominant (left) thumb and index finger while the dominant (right) index and middle fingers are inserted into the vagina gently to access the cervix. The right middle finger is introduced first into the fourchette depressing it backward to create more room, followed by introduction of the right index finger. The fingers are advanced into the vagina towards the cervix. The Bishop score is gently assessed and recorded for both groups. For the study group, the right middle finger of the examining hand is inserted into the cervical canal through the external and internal os to access the lower pole of the fetal membrane. Where the cervical canal permits two fingers (the right index and middle fingers) both are used to sweep the membrane. The examining finger or fingers is further insinuated from the internal cervical os in-between the lower pole of the fetal membrane and apposing lower uterine segment to a distance of 2-3cm inside the lower uterine cavity. Where the membrane could not be reached, digital stretching of the cervical canal will be done followed by the sweeping. The finger is gently rotated round the lower uterine segment separating the lower fetal membrane from apposing lower uterine segment through a circumferential 360 degree. For the purpose of this study, the circumferential rotation or movement will be done three times within one minute. After the procedure, the examining fingers are withdrawn and the participant cleaned up. The used gloves are discarded in the waste-bin. The participant is observed while sitting comfortably on a chair in the antenatal clinic for 30 minutes for any event 34
Control Group NO MEMBRANE SWEEPING ONLY ONCE ONE MINUTE The participant will empty her urinary bladder and lie comfortably in dorsal position on the examination couch at the examining room of the antenatal clinic. The principal investigator washes his hands with soap and water and wears sterile surgical gloves on both hands. The participant’s vulva will be swabbed with 3 gauze soaked in salon. The vulva is parted with less dominant (left) thumb and index finger while the dominant (right) index and middle fingers are inserted into the vagina gently to access the cervix for Bishop Score assessment only. The right middle finger is introduced first into the fourchette depressing it backward to create more room, followed by introduction of the right index finger. The fingers are advanced into the vagina towards the cervix. The Bishop score is gently assessed and recorded for the group. For the control group, membrane sweeping will not be done. Vaginal examination and Bishop score are done with no membrane sweeping in this control group. After the procedure, the examining fingers are withdrawn and the participant cleaned up. The used gloves are discarded in the waste-bin. The participant is observed while sitting comfortably on a chair in the antenatal clinic for 30 minutes for any event 34 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The pregnant women that will be recruited for this study must be booked with uncomplicated pregnancy. The participants must be a multiparous pregnant woman with one previous transverse lower uterine segment caesarean section. They will be within the age of 18-44 years. The women should be at full term pregnancy (from 39 weeks to 40 weeks plus 6 days of gestation). They must be fit for vaginal delivery after one caesarean section. Participants should be women with a normal size single fetus (2.5kg -3.5kg at 36 weeks GA) in cephalic presentation and longitudinal lie with no contraindication to vaginal delivery. The fetal membrane should be intact and the woman must not be in labour. They should present within the study period of six months. Participants should be motivated and must give a written informed consent to participate in the study. This study will exclude pregnant women with unsure date and with no early ultrasound dating. Pregnant women with preterm labour, post-term pregnancy, fetal anomalies and intrauterine fetal death will be excluded. Participants that are primipara and grand-multipara with one previous caesarean section will be excluded. Any woman with classical caesarean section, two or more caesarean section, previous uterine rupture or any other previous uterine surgery like myomectomy, polypectomy, cervical cerclage etc will be excluded. Also excluded are participants with contraindication to vaginal delivery and Participants that are not fit for vaginal birth after caesarean section. All pregnancies with antepartum haemorrhage like placenta previa, abruptio placentae, vasa previa and unexplained vaginal bleeding will be excluded. Participants with medical conditions like diabetes mellitus, hypertensive disorders, sickle cell disease, renal disease, human immunodeficiency virus etc will be excluded. The obese women and women with significant fibroid will be excluded from study. Women with un-accessible cervix or close cervix will be excluded. Those that withhold consent will be excluded from the study. Those already scheduled or booked for elective vaginal delivery or caesarean section will be excluded. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 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 31/07/2026 NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL HEALTH RESEARCH ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
NUMBER 60 OLD OBA ROAD NNEWI 434116 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the number of participants that will have prolonged pregnancy (pregnancy that exceeds 41 weeks plus 3 days). When pregnancy gets to 41 weeks plus 3 days
Secondary Outcome The number of participants that will have spontaneous onset of labour The number of participants that will have successful VBAC The number of participants who will have repeat caesarean section. The Apgar score of the neonate at delivery. 1. After delivery 2. When pregnancy is prolonged 3.When onset of labour starts 4.After delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL HEALTH NUMBER 60 OLD OBA ROAD NNEWI 434116 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OKOYE SAMUEL CHIDIEBERE OKOYES COMPOUND, NNABOCHI VILLAGE, UMUAHAMA, UKPOR Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OKOYE SAMUEL CHIDIEBERE OKOYES COMPOUND, NNABOCHI VILLAGE, UMUAHAMA, ukpor Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Okoye Samuel Chidiebere okoyesamuel27@gmail.com +2348065143198 OKOYES COMPOUND, NNABOCHI VILLAGE, UMUAHAMA,
City Postal code Country Position/Affiliation
ukpor Nigeria senior registrar
Role Name Email Phone Street address
Public Enquiries Umeononihu Samuel Osita osita.umeononihu@npmcn.edu.ng +2348037123770 NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Oguejiofor Charlotte Blanche Ojmumm@gmail.com +2348034059712 NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI
City Postal code Country Position/Affiliation
nnewi Nigeria consultant
Role Name Email Phone Street address
Scientific Enquiries Eleje George Uchenna elejegeorge1@gmail.com +2348068117444 NNAMDI AZIKIWE UNIVERSITY TEACHING HOSPITAL NNEWI
City Postal code Country Position/Affiliation
nnewi Nigeria consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The raw data will be shared with any organisations and researchers that may require them Informed Consent Form for one year pubmed, Google Scholar, online media, journals
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 04/09/2026 The public tittle were all initially in capital letters ONCE-ONLY MEMBRANE SWEEPING AT FULL-TERM FOR PREVENTING PROLONGED PREGNANCY IN MULTIPAROUS WOMEN WITH ONE PREVIOUS CAESAREAN SECTION: A DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL AT NAUTH, NNEWI, NIGERIA. Once-only membrane sweeping at full-term for preventing prolonged pregnancy in multiparous women with one previous caesarean section: A double-blind randomised controlled trial at NAUTH, Nnewi, Nigeria.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 04/09/2026 The official scientific tittle were all initially in capital letters ONCE-ONLY MEMBRANE SWEEPING AT FULL-TERM FOR PREVENTING PROLONGED PREGNANCY IN MULTIPAROUS WOMEN WITH ONE PREVIOUS CAESAREAN SECTION: A DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL AT NAUTH, NNEWI, NIGERIA, Once-only membrane sweeping at full-term for preventing prolonged pregnancy in multiparous women with one previous caesarean section: A double-blind randomised controlled trial at NAUTH, Nnewi, Nigeria.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 04/09/2026 the age changed from 18 years -45 years To 18 years -44 years The pregnant women that will be recruited for this study must be booked with uncomplicated pregnancy. The participants must be a multiparous pregnant woman with one previous transverse lower uterine segment caesarean section. They will be within the age of 18-45 years. The women should be at full term pregnancy (from 39 weeks to 40 weeks plus 6 days of gestation). They must be fit for vaginal delivery after one caesarean section. Participants should be women with a normal size single fetus (2.5kg -3.5kg at 36 weeks GA) in cephalic presentation and longitudinal lie with no contraindication to vaginal delivery. The fetal membrane should be intact and the woman must not be in labour. They should present within the study period of six months. Participants should be motivated and must give a written informed consent to participate in the study. The pregnant women that will be recruited for this study must be booked with uncomplicated pregnancy. The participants must be a multiparous pregnant woman with one previous transverse lower uterine segment caesarean section. They will be within the age of 18-44 years. The women should be at full term pregnancy (from 39 weeks to 40 weeks plus 6 days of gestation). They must be fit for vaginal delivery after one caesarean section. Participants should be women with a normal size single fetus (2.5kg -3.5kg at 36 weeks GA) in cephalic presentation and longitudinal lie with no contraindication to vaginal delivery. The fetal membrane should be intact and the woman must not be in labour. They should present within the study period of six months. Participants should be motivated and must give a written informed consent to participate in the study.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/09/2026 correction from reviewer to remove group from intervention name Experimental Group, Membrane sweeping group, ONLY ONCE, ONE MINUTE, The participant will empty her urinary bladder and lie comfortably in dorsal position on the examination couch at the examining room of the antenatal clinic. The principal investigator washes his hands with soap and water and wears sterile surgical gloves on both hands. The participant’s vulva will be swabbed with 3 gauze soaked in salon. The vulva is parted with less dominant (left) thumb and index finger while the dominant (right) index and middle fingers are inserted into the vagina gently to access the cervix. The right middle finger is introduced first into the fourchette depressing it backward to create more room, followed by introduction of the right index finger. The fingers are advanced into the vagina towards the cervix. The Bishop score is gently assessed and recorded for both groups. For the study group, the right middle finger of the examining hand is inserted into the cervical canal through the external and internal os to access the lower pole of the fetal membrane. Where the cervical canal permits two fingers (the right index and middle fingers) both are used to sweep the membrane. The examining finger or fingers is further insinuated from the internal cervical os in-between the lower pole of the fetal membrane and apposing lower uterine segment to a distance of 2-3cm inside the lower uterine cavity. Where the membrane could not be reached, digital stretching of the cervical canal will be done followed by the sweeping. The finger is gently rotated round the lower uterine segment separating the lower fetal membrane from apposing lower uterine segment through a circumferential 360 degree. For the purpose of this study, the circumferential rotation or movement will be done three times within one minute. After the procedure, the examining fingers are withdrawn and the participant cleaned up. The used gloves are discarded in the waste-bin. The participant is observed while sitting comfortably on a chair in the antenatal clinic for 30 minutes for any event, 34, Experimental Group, Membrane sweeping , ONLY ONCE, ONE MINUTE, The participant will empty her urinary bladder and lie comfortably in dorsal position on the examination couch at the examining room of the antenatal clinic. The principal investigator washes his hands with soap and water and wears sterile surgical gloves on both hands. The participant’s vulva will be swabbed with 3 gauze soaked in salon. The vulva is parted with less dominant (left) thumb and index finger while the dominant (right) index and middle fingers are inserted into the vagina gently to access the cervix. The right middle finger is introduced first into the fourchette depressing it backward to create more room, followed by introduction of the right index finger. The fingers are advanced into the vagina towards the cervix. The Bishop score is gently assessed and recorded for both groups. For the study group, the right middle finger of the examining hand is inserted into the cervical canal through the external and internal os to access the lower pole of the fetal membrane. Where the cervical canal permits two fingers (the right index and middle fingers) both are used to sweep the membrane. The examining finger or fingers is further insinuated from the internal cervical os in-between the lower pole of the fetal membrane and apposing lower uterine segment to a distance of 2-3cm inside the lower uterine cavity. Where the membrane could not be reached, digital stretching of the cervical canal will be done followed by the sweeping. The finger is gently rotated round the lower uterine segment separating the lower fetal membrane from apposing lower uterine segment through a circumferential 360 degree. For the purpose of this study, the circumferential rotation or movement will be done three times within one minute. After the procedure, the examining fingers are withdrawn and the participant cleaned up. The used gloves are discarded in the waste-bin. The participant is observed while sitting comfortably on a chair in the antenatal clinic for 30 minutes for any event, 34,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 04/09/2026 correction from reviewer The date/ information will be obtained the participants last menstrual period, at recruitment during vaginal examination, time of onset of labour, time of delivery, gestational age at delivery, any caesarean section and Apgar score of neonate at delivery. Data will be documented and tabulated. The raw data will be shared with any organisations and researchers that may require them
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 04/09/2026 to include only adults (18-44 years) 45 Year(s) 44 Year(s)