Cesarean Section Complications, Uterine Bleeding
Conditions
Brief summary
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.
Interventions
PROCEDURENiche prevention suture
This group will have the uterus sutured in two layers using a new technique.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Formation of a uterine niche | At least 12 weeks after delivery. | Presence of a uterine niche on ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgery | At surgery | Total duration of surgery |
| Blood loss over 1000 mL | At surgery | As assessed by the operating surgeon |
| Postoperative infection | Up to 6 weeks after intervention | The number of patients who are diagnosed with postoperative infection including endometritis or wound infection. |
| Need for repeat laparotomy | Up to 6 weeks after intervention | The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained. |
| Formation of a n abscess/hematoma | Up to 6 weeks after intervention | 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. |
Countries
Israel
Contacts
Primary ContactHadas Lemberg, PhD
Outcome results
None listed