Role of Membrane Sweeping on Initiation of Labor and Vaginal Birth in Previous Cesarean Section

Sponsor
HITEC-Institute of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT06103071
Collaborator
(none)
384
1
2
18.5
20.7

Study Details

Study Description

Brief Summary

In Pakistan rate of child birth through cesarean section increased from 3.2% in 1992 to 22% in 2018 .Due to increasing rates of cesarean sections and associated morbidity the investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. This is a randomized controlled trial. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sweeping of membranes
N/A

Detailed Description

World Health Organization suggests that ideally cesarean section rate should not be more than 10% to 15%. The investigators should focus to reduce rate of primary cesarean section as well as repeat cesarean with cephalic presentation and singleton pregnancy after previous 1 cesarean section. Therefore, all ladies who underwent previous 1 cesarean section for non-recurrent cause should be considered for vaginal birth. Though studies show that membrane sweeping does promote the onset of labor and avoid need for formal induction of labor for prolonged pregnancy but the effects of membrane sweeping in women with a prior cesarean delivery are largely unknown. It is reported in literature that there is no significant increase risk to maternal or neonatal outcome with membrane sweeping. The rationale of the study was to compare the effect of membrane sweeping with no sweeping in the successful onset of labor in patients with one previous Cesarean Section so that the investigators can reduce the cesarean section rate. Objective of the study was to determine the effect of membrane sweeping on the onset of labor, success of vaginal delivery and neonatal outcome in patients with previous one cesarean section.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomization intervention RCTrandomization intervention RCT
Masking:
Single (Participant)
Masking Description:
lottery method for selection
Primary Purpose:
Prevention
Official Title:
Effectiveness of Membrane Sweeping on Successful Initiation of Labor and Subsequent Vaginal Birth in Patients With Previous One Cesarean Section.
Actual Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sweeping group

Sweeping group include patients in which membrane sweeping started from 37 weeks and performed weekly till 40 weeks. Intervention is the sweeping of membranes from 37 weeks of gestational amenorrhea.

Procedure: Sweeping of membranes
After informed consent all the patients in interventional group will have sweeping of membranes from 37 weeks of pregnancy . It will be repeated weekly till 40 weeks.

No Intervention: Non sweeping group

Non sweeping group include patients in which no sweeping of membranes done. No intervention done.

Outcome Measures

Primary Outcome Measures

  1. Number of participants who will have onset of labour till 40 weeks [4 weeks]

    Primary outcome include number of participants who will have onset of labour till 40 weeks between two groups ( sweeping and non sweeping groups )

Secondary Outcome Measures

  1. Number of participants having successful vaginal delivery and number of participants having babies admitted in NICU [5 days]

    It includes how many number of participants will have successful vaginal birth after previous 1 cesarean section and fetal outcome, that is admission in NICU.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
    1. Women willing for vaginal birth after lower segment cesarean section from 37 weeks of gestation to 40 weeks.
  1. Previous one caesarean section for non-recurrent cause 3. Singleton pregnancy 4. Cephalic presentation
Exclusion Criteria:
  1. Previous uterine rupture

  2. Major degree placenta previa

  3. Any medical disorder like PIH, diabetes

  4. Bad obstetrics history

Contacts and Locations

Locations

Site City State Country Postal Code
1 HIT hospital Rawalpindi Punjab Pakistan 47080

Sponsors and Collaborators

  • HITEC-Institute of Medical Sciences

Investigators

  • Principal Investigator: Nida Khan, MBBS, FCPS, HITEC-Institute of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nida Khan, Principal investigator, HITEC-Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT06103071
Other Study ID Numbers:
  • HITEC-IMS
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 26, 2023