Vaginal Birth After Cesarean Section
Conditions
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.
Interventions
PROCEDURESweeping 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.
Sponsors
HITEC-Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
lottery method for selection
Intervention model description
randomization intervention RCT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Onset of Labor by 40 Weeks | Primary outcome include number of participants that had onset of labour from enrollment upto 40 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having Successful Vaginal Delivery | 4 weeks | It includes how many number of participants will have successful vaginal birth after previous 1 cesarean section |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORNida Khan, MBBS, FCPS
HITEC-Institute of Medical Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.54 years STANDARD_DEVIATION 6.72 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Pakistan | 192 Participants |
| Sex: Female, Male Female | 192 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 90 |
| other Total, other adverse events | 0 / 119 | 0 / 90 |
| serious Total, serious adverse events | 0 / 119 | 0 / 90 |
Outcome results
None listed