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This study is designed to compare the exteriorization of the uterus versus the in situ repair for closure of the hysterotomy incision with a completely standardized anesthetic protocol.
Two well-known uterine repair techniques are described; the uterus can be repaired in situ within the peritoneal cavity (intraabdominal) or exteriorized temporarily from the abdomen for the closure of the hysterotomy incision (extraabdominal). 3 meta-analysis on the topic were unable to demonstrate the superiority of one technique regarding maternal morbidities. However, there is a paucity of studies with a standardized anesthetic protocol evaluating these outcomes.
This study will evaluate the impact of the uterine repair technique on different maternal morbidities; focusing on intra-operative nausea and vomiting under a standardized anesthetic protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In situ uterine repair | Experimental | The uterus is repaired in situ within the abdominal cavity, without exteriorization; intra-abdominal repair |
|
| Exteriorization of the uterus | Active Comparator | The uterine incision is repaired with the exteriorization of the uterus; extra-abdominal repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type A of uterine repair: In situ | Procedure | The uterine incision is closed with the uterus within the abdominal cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative nausea and vomiting | Incidence of intraoperative nausea and vomiting using a scale of 0 to 3; 0 being no nausea, 1 being light nausea, 2 being severe nausea, and 3 being nausea accompanied with vomiting and / or retching. The patients will be questioned at 5 pre-determined time points during the cesarean delivery. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension | Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion | Intraoperative |
| Pelvic irrigation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Zaphiratos, MD | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32282591 | Derived | Mireault D, Loubert C, Drolet P, Tordjman L, Godin N, Richebe P, Zaphiratos V. Uterine Exteriorization Compared With In Situ Repair of Hysterotomy After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1145-1151. doi: 10.1097/AOG.0000000000003821. |
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| Type B of uterine repair: Exteriorization | Procedure | The uterine incision is repaired with the exteriorization of the uterus |
|
|
To determine if the patient had pelvic irrigation, yes or no
| Intraoperative |
| Length of surgery | Intraoperative |
| Estimated blood loss | Measuring suction canisters and wet sponges | Intraoperative |
| Reduction in hemoglobin | Difference between preoperative and postoperative hemoglobin within 24 hours of surgery | Within 24 hours of surgery |
| Incidence of endometritis | Through study completion; on average of 1 year |
| Time to return of bowel function | The return of bowel function will be assessed by listening to each of the four abdominal quadrants for intestinal peristalsis with a stethoscope twice a day and by assessing the time of the first gas or bowel movement. The first occurrence of any of these events will determine the return of intestinal transit. | Up to 2 weeks |
| Length of hospital stay after the cesarean delivery | Through study completion on average of 1 year |
| Incidence of tachycardia | Tachycardia, defined as a heart rate above 100 beats per minute | Intraoperative |