Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Study Overview
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Brief Summary
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In the last decade we have been exposed to the complication of a caesarean section called a niche. A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section. In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.

Official Title
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Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

Conditions
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Uterine Bleeding, Cesarean Section Complications

Intervention / Treatment
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* Procedure: Niche prevention suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women at first cesarean delivery Women who consent to the study Exclusion Criteria: Women who are having a repeat caesarean section Refusal to participate in the study Urgent or emergent cesarean delivery

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Closure Technique<br>This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique. | Procedure: Niche prevention suture<br>* This group will have the uterus sutured in two layers using a new technique.<br>|
| No Intervention: Regular closure technique<br>The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formation of a uterine niche | Presence of a uterine niche on ultrasound | At least 12 weeks after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery | Total duration of surgery | At surgery | 
| Blood loss over 1000 mL | As assessed by the operating surgeon | At surgery | 
| Postoperative infection | The number of patients who are diagnosed with postoperative infection including endometritis or wound infection. | Up to 6 weeks after intervention | 
| Need for repeat laparotomy | The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained. | Up to 6 weeks after intervention | 
| Formation of a n abscess/hematoma | The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery. | Up to 6 weeks after intervention |