Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery
Primary Purpose
Vomiting, Nausea, Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spinal Anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Vomiting focused on measuring Cesarean delivery, Spinal anesthesia, Nausea, Vomiting, Pain
Eligibility Criteria
Inclusion Criteria:
- Healthy pregnant women scheduled for elective cesarean delivery
Exclusion Criteria:
- ASA III or IV patients
- Patient with conditions that predispose to uterine atony and post partum hemorrhage
Sites / Locations
- Mount Sinai Hospital
Outcomes
Primary Outcome Measures
Intraoperative nausea or vomiting after deliver of the infant
Secondary Outcome Measures
Intraoperative pain
Calculated blood loss
Uterine contractility
Hypotension
Heart rate changes
Duration of uterine repair
Full Information
NCT ID
NCT00452972
First Posted
March 19, 2007
Last Updated
March 26, 2007
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00452972
Brief Title
Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery
Official Title
Complications of Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery Under Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in patients undergoing elective CD under a strictly standardized spinal anesthetic. We hypothesized that in situ uterine repair would be more comfortable for the patients.
Detailed Description
Uterine repair during Cesarean delivery can be done either by exteriorizing the uterus and replacing it into the abdominal cavity after the completion of a double layer closure, or by suturing it in situ. Exteriorization of the uterus has been shown to decrease blood loss during Cesarean delivery when compared to in situ repair. However, at the same time, it is thought to be uncomfortable for the patient with respect to intraoperative nausea, vomiting and pain. Intraoperative nausea and vomiting in patients who receive regional anaesthesia for Cesarean section is a complex multifactorial problem arising from anesthetic and non-anesthetic causes. Additionally, it can influence hemodynamic stability.
The study was a prospective, randomized and single blinded study. It compared the effects of exteriorization of the uterus and in-situ repair during Cesarean delivery with respect to patient's comfort, hemodynamic changes, uterine contractility and blood loss in patients under spinal anesthesia. All low risk patients undergoing elective C-delivery under spinal anesthesia were considered for this study.
Spinal anesthesia was performed in the sitting position with 10-12 mg of 0.75% hyperbaric bupivacaine, mixed with 100 mcg of preservative free morphine and 10 mcg of fentanyl. Any drop in blood pressure was treated with 100 mg of phenylephrine titrated to maintain systolic blood pressure within 10% of the baseline values throughout the procedure. Oxytocin was used judiciously, in aliquots of 0.5 IU. Obstetricians were asked to allow assisted spontaneous delivery of placenta rather than manual extraction. During surgery, patient's complaints of nausea, vomiting, pain or any discomfort were recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting, Nausea, Pain, Hypotension, Tachycardia
Keywords
Cesarean delivery, Spinal anesthesia, Nausea, Vomiting, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Spinal Anesthesia
Primary Outcome Measure Information:
Title
Intraoperative nausea or vomiting after deliver of the infant
Secondary Outcome Measure Information:
Title
Intraoperative pain
Title
Calculated blood loss
Title
Uterine contractility
Title
Hypotension
Title
Heart rate changes
Title
Duration of uterine repair
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy pregnant women scheduled for elective cesarean delivery
Exclusion Criteria:
ASA III or IV patients
Patient with conditions that predispose to uterine atony and post partum hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD PhD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17766602
Citation
Siddiqui M, Goldszmidt E, Fallah S, Kingdom J, Windrim R, Carvalho JC. Complications of exteriorized compared with in situ uterine repair at cesarean delivery under spinal anesthesia: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):570-5. doi: 10.1097/01.AOG.0000277712.67230.22.
Results Reference
derived
Learn more about this trial
Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery
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