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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sweeping group | Active Comparator | 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. |
|
| Non sweeping group | No Intervention | Non sweeping group include patients in which no sweeping of membranes done. No intervention done. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sweeping of membranes | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Having Successful Vaginal Delivery | It includes how many number of participants will have successful vaginal birth after previous 1 cesarean section | 4 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Nida Khan, MBBS, FCPS | HITEC-Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIT hospital | Rawalpindi | Punjab Province | 47080 | Pakistan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sweeping Group | Sweeping group include patients in which membrane sweeping started from 37 weeks and performed weekly till the onset of labor or 40 weeks. Intervention is the sweeping of membranes from 37 weeks of gestational amenorrhea. 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 onset of labor or 40 weeks. |
| FG001 | Non Sweeping Group | Non sweeping group include patients in which no sweeping of membranes done. No intervention done. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sweeping Group | Sweeping group include patients in which membrane sweeping started from 37 weeks and performed weekly till onset of labor or 40 weeks. Intervention is the sweeping of membranes from 37 weeks of gestational amenorrhea. 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 onset of labor or 40 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Onset of Labor by 40 Weeks | Posted | Number | 95% Confidence Interval | participants | Primary outcome include number of participants that had onset of labour from enrollment upto 40 weeks gestation |
|
From start of labor upto 24 hours later
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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This study's limitation is the small sample size, and further studies with large sample sizes are needed to know the effect of membrane sweeping in patients with previous cesarean sections
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nida Khan | HITEC IMS | 03218544342 | nidz742@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 15, 2023 | Nov 19, 2025 | Prot_SAP_ICF_000.pdf |
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randomization intervention RCT
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lottery method for selection
| BG001 | Non Sweeping Group | Non sweeping group include patients in which no sweeping of membranes done. No intervention done. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| Secondary | Number of Participants Having Successful Vaginal Delivery | It includes how many number of participants will have successful vaginal birth after previous 1 cesarean section | Posted | Number | participants | 4 weeks |
|
|
|
| 0 |
| 119 |
| 0 |
| 119 |
| 0 |
| 119 |
| EG001 | Non Sweeping Group | Non sweeping group include patients in which no sweeping of membranes done. No intervention done. | 0 | 90 | 0 | 90 | 0 | 90 |
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