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

NCT ID: NCT06103071

Last Updated: 2023-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaginal Birth After Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomization intervention RCT
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
lottery method for selection

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Sweeping of membranes

Intervention Type PROCEDURE

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.

Non sweeping group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Women willing for vaginal birth after lower segment cesarean section from 37 weeks of gestation to 40 weeks.

2\. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nida Khan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nida Khan, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

HITEC-Institute of Medical Sciences

Locations

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HIT hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Nida Khan, MBBS, FCPS

Role: CONTACT

03218544342

mahwash Jamil, MBBS, FCPS

Role: CONTACT

03315405959

Facility Contacts

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Nida Khan, MBBS, FCPS

Role: primary

00923218544342

Rukhsana Shaheen, MBBS, FCPS

Role: backup

00923339014943

Other Identifiers

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HITEC-IMS

Identifier Type: -

Identifier Source: org_study_id

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