A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

Study Overview
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Brief Summary
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The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.

Official Title
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A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean

Conditions
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Labor Pain

Intervention / Treatment
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* Other: Transperitoneal cesarean technique
* Other: Extraperitoneal cesarean technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective cesarean previous cesarean (<4) cesarean for distocia Exclusion Criteria: emergency cesarean ( fetal distress) risk of obstetrical bleeding maternal coagulation defects adnexial mass uterin myoma at incision site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extraperitoneal cesarean<br> | Other: Extraperitoneal cesarean technique<br>* Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry<br>|
| Active Comparator: Transperitoneal cesarean<br> | Other: Transperitoneal cesarean technique<br>* Pfannenstiel-Kerr technique for laparatomy and uterine entry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin-to-delivery time |  | 1 minute after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Pain will be measured by VAS | 24 and 48 hour after cesarean | 
| Operation time | skin-to-skin operation time | Two minutes after surgery | 
| Hemoglobin differences |  | One hour before cesarean and 48 hours after cesarean | 
| Need for analgesic | All analgesic given after cesarean at hospital | 24 and 48 hours after cesarean | 
| Nausea | Nausea during surgery and after surgery | Two minutes and 48 hours after cesarean | 
| Vomiting | Nausea during and after surgery | Two minutes and 48 hours after cesarean | 
| Thoracic shoulder pain | Thoracic shoulder pain after surgery | 48 hours after cesarean | 
| Urogenital distress measured by Urogenital Distress Inventory |  | One hour before cesarean and 24 hours after cesarean | 
| Oral intake | The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hours after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas. | 12 and 24 hours postoperatively | 
| Anxiety during surgery | Intense fear or anxiety during surgery without pain (yes or no) | One minute after cesarean | 
| Pain during surgery | Abdominal pain during surgery (yes or no) | One minutes after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extra-peritoneal cesarean, Intra-peritoneal cesarean