Comparison of FAUCS vs. Misgav Ladach

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-19

Study Completion Date

2019-09-19

Brief Summary

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This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.

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Detailed Description

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The FAUCS technique for performing a cesarean section has been described by a French group several years ago, and is claimed to reduce postoperative pain and increase ambulation. With this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. No urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. The patient is encouraged to get out of bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.

Conditions

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Pain, Postoperative Ambulation Difficulty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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FAUCS

Patients undergoing a cesarean section using the FAUCS technique

Group Type EXPERIMENTAL

French Abulatory Cesrean Section

Intervention Type PROCEDURE

A cesarean section performed according to the FAUCS technique

Control

Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique

Group Type ACTIVE_COMPARATOR

Misgav-Ladach

Intervention Type PROCEDURE

A cesarean section performed according to the Misgav Ladach technique

Interventions

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French Abulatory Cesrean Section

A cesarean section performed according to the FAUCS technique

Intervention Type PROCEDURE

Misgav-Ladach

A cesarean section performed according to the Misgav Ladach technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for a cesarean section
* term pregnancy: 37-42 weeks
* singleton pregnancy
* age 18 and above
* patients capable of signing an informed consent

Exclusion Criteria

* multiple pregnancy
* emergency cesarean
* previous 3 cesareans and above
* placenta accreta
* uterine myomas in the lower segment
* fetal growth restriction
* fetal anemia
* preeclampsia
* women scheduled for general anesthesia

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes