Clinical trial NCT06103071: Role of Membrane Sweeping on Initiation of Labor and Vaginal Birth in Previous Cesarean Section
Official title: Effectiveness of Membrane Sweeping on Successful Initiation of Labor and Subsequent Vaginal Birth in Patients With Previous One Cesarean Section.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Birth After Cesarean Section
Lead sponsor: HITEC-Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 384
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization intervention RCT
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who will have onset of labour till 40 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of participants having successful vaginal delivery and number of participants having babies admitted in NICU
timeFrame: 5 days
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: HIT hospital
state: Punjab
Study officials:
affiliation: HITEC-Institute of Medical Sciences
name: Nida Khan, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References: