Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452972
Status:
COMPLETED
Last Update Posted:
2007-03-28
First Post:
2007-03-19
Brief Title:
Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Complications of Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery Under Spinal Anesthesia
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 075 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 05 IU Obstetricians were asked to allow assisted spontaneous delivery of placenta rather than manual extraction During surgery patients complaints of nausea vomiting pain or any discomfort were recorded
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 patients 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 075 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 05 IU Obstetricians were asked to allow assisted spontaneous delivery of placenta rather than manual extraction During surgery patients complaints of nausea vomiting pain or any discomfort were recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-0057-A | None | None | None |