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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Closure Technique | Experimental | This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique. |
|
| Regular closure technique | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niche prevention suture | Procedure | This group will have the uterus sutured in two layers using a new technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Formation of a uterine niche | Presence of a uterine niche on ultrasound | At least 12 weeks after delivery. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadas Lemberg, PhD | Contact | +972 2 6777572 | lhadas@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Hila Hochler, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |