Complications; Cesarean Section
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREType A of uterine repair: In situ
The uterine incision is closed with the uterus within the abdominal cavity
PROCEDUREType B of uterine repair: Exteriorization
The uterine incision is repaired with the exteriorization of the uterus
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elective cesarean delivery * Term gestation, 37 weeks or more * Healthy parturients (ASA 1 and 2) * Spinal anesthesia
Exclusion criteria
* Conditions at risk of uterine atony and/or postpartum hemorrhage (multiple gestation, placenta accrete / previa, pre-eclampsia / eclampsia, uterine leiomyomata, polyhydramnios) * Morbid obesity (BMI \> 35 kg / m2) at delivery * Coagulopathy * Active labor * Cardiomyopathy * Emergency cesarean section * Refusal/Inability to consent * Language other than English or French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative nausea and vomiting | Intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic irrigation | Intraoperative | To determine if the patient had pelvic irrigation, yes or no |
| Length of surgery | Intraoperative | — |
| Estimated blood loss | Intraoperative | Measuring suction canisters and wet sponges |
| Reduction in hemoglobin | Within 24 hours of surgery | Difference between preoperative and postoperative hemoglobin within 24 hours of surgery |
| Incidence of hypotension | Intraoperative | Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion |
| Time to return of bowel function | Up to 2 weeks | 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. |
| Length of hospital stay after the cesarean delivery | Through study completion on average of 1 year | — |
| Incidence of tachycardia | Intraoperative | Tachycardia, defined as a heart rate above 100 beats per minute |
| Incidence of endometritis | Through study completion; on average of 1 year | — |
Countries
Canada
Outcome results
None listed