Effectiveness of Membrane Sweeping on Successful Initiation of Labor and Subsequent Vaginal Birth in Patients With Previous One Cesarean Section.
Phase: NA
Conditions: Vaginal Birth After Cesarean Section
Sponsor: HITEC-Institute of Medical Sciences

TITLE 
Effectiveness of membrane sweeping on successful initiation of labor and 
subsequent vaginal birth in patients with previous one cesarean section. 
 
NCT No. 06103071 
Date  15th Jan, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
This Randomized controlled trial was conducted at HIT Hospital, Taxila, in collaboration with 
POF Hospital, Wah Cantt, from 15th Jan 2023 to 15th July 2024. The determined sample size 
overall amounts to 384 patients. The sample size is determined using the WHO calculator by 
calculating a 95% confidence interval, 80% statistical power, and a % expected success rate of 
50% using membrane sweeping. 
Women at gestational age of 37 weeks to 40 weeks who were willing for vaginal birth and who 
had a history of one prior caesarean procedure for non-recurrent reasons were included in the 
research. Females with multiple gestation or non-cephalic presentations, previous uterine rupture, 
major degree placenta previa, medical disorders like pregnancy-induced hypertension, gestational 
or chronic diabetes or having bad obstetrics history were excluded from the study. 
 The trial was registered in the clinical trial registry after obtaining approval from the institutional 
review board of HITEC-IMS and Wah Medical College. Patients with previous cesarean sections 
attending the gynaecology department at HIT Hospital and POF Hospital who fulfilled the 
inclusion criteria were enrolled, and informed consent was obtained. Two groups were made by 
using the lottery method. Group A is an interventional group in which membrane sweeping was 
done. Group B is a control group that includes women without membrane sweeping. The lottery 
method was used to randomly assign patients to either group A or B so every patient has an equal 
chance of getting selected for intervention. For membrane sweeping, the doctor inserts one or two 
fingers into the cervix and continuously sweeps the inferior pole of the membranes from the lower 
uterine segment. Weekly membrane sweeping was done starting at 37 weeks till the initiation of 
labour or 40 weeks of gestation, whichever happened first. Patients in which spontaneous labour 
did not start till 40 weeks were planned for elective cesarean section in the next operation theatre 
list according to the protocol of the department. Numerical data, including age and parity, were 
recorded. The primary outcome measures the number of patients who had onset of labour till 40 
weeks. Secondary outcome measures of successful vaginal delivery and fetal outcome, i.e. 
admission to NICU, were recorded. 
 
 

Data Analysis Plan 
 
All data was entered and analyzed using computer software for statistical package for the social 
sciences (SPSS) version 28. Mode of delivery and admission in NICU were compared in both 
groups using the chi-square test. P value <0.05 was considered as significant. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Consent Form  
This study is conducted to increase the onset of labor in patients with previous one cesarean section 
in order to reduce cesarean section rate. Your confidentiality and privacy will be ensured. In this 
study we have divided patients in two groups. Group A includes women in which membrane 
sweeping will be done and group B includes women in which no membrane sweeping will be 
done. Group will be allocated on random basis and you may be included in any group. 
 
If you go in labor then success of vaginal birth is 72% to 75%. Your chances of vaginal birth are 
increased in future pregnancies with shorter hospital stay. In case of vaginal birth you will be 
prevented from risks of operation and more likely to have immediate skin to skin contact with 
baby and able to breastfeed successfully. 
Along with above mentioned benefits there is also a risk of having emergency caesarean section 
during labor and its incidence is 25 out of 100 women. 1 in 200 women is at risk of having scar 
dehiscence (rupture). This risk increases by 2 to 3 times if your labor is induced by 
pharmacological methods. Being a non-pharmacological method, sweeping of membranes causes 
no significant harm to mother or baby. 
I have read the consent and understood its content and I therefore, give my willingness for 
participation in the study. 
 
Signature 
--------------------------------