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

H

HITEC-Institute of Medical Sciences

Status

Enrolling

Conditions

Vaginal Birth After Cesarean Section

Treatments

Procedure: Sweeping of membranes

Study type

Interventional

Funder types

Other

Identifiers

NCT06103071
HITEC-IMS

Details and patient eligibility

About

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.

Full 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.

Enrollment

384 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

384 participants in 2 patient groups

Sweeping group
Active Comparator group
Description:
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.
Treatment:
Procedure: Sweeping of membranes
Non sweeping group
No Intervention group
Description:
Non sweeping group include patients in which no sweeping of membranes done. No intervention done.

Trial contacts and locations

1

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Central trial contact

Nida Khan, MBBS, FCPS; mahwash Jamil, MBBS, FCPS

Data sourced from clinicaltrials.gov

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