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OpenTrials
Completed

NCT Number: NCT00452972

Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal anesthesia

Drug

Primary outcomes

  1. Intraoperative nausea or vomiting after deliver of the infant

Secondary outcomes

  1. Intraoperative pain

  2. Calculated blood loss

  3. Uterine contractility

  4. Hypotension

  5. Heart rate changes

  6. Duration of uterine repair

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Complications of Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery Under Spinal Anesthesia

Important dates

Study start
2004
Study completion
2004
First posted
Mar 28, 2007
Registry last updated
Mar 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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