Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Vomiting Nausea Pain Hypotension Tachycardia

Keywords

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Cesarean delivery Spinal anesthesia Nausea Vomiting Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Spinal Anesthesia

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Jose CA Carvalho, MD PhD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 17766602 (View on PubMed)

Other Identifiers

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04-0057-A

Identifier Type: -

Identifier Source: secondary_id

07-04