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Extra - Abdominal Versus Intra - Abdominal Repair of the Uterine Incision at Cesarean Section

NCT02373501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-12-04

No results posted yet for this study

Summary

To evaluate the effects of extra-abdominal repair of the uterine incision compared to intra-abdominal repair, and to study is there superiority of one technique over the other in terms of primary outcomes - operative( up to 4 hours after beginning of anesthesia) and post operative ( until day 4 after operation ) measurements , secondary outcomes, long-term outcomes and subjective outcomes.

PRIMARY OUTCOMES:

Intra - operative ( during the operation up to 4 hours from anesthesia )

* nausea and vomiting
* intraoperative hypotension
* intraoperative pain

Post operative ( 4 hours from anesthesia and until release from hospital )

* Blood transfusion
* Venous thromboembolism
* Febrile Morbidity
* Endometritis
* Wound Infection
* Death

Subjective measures:

* complain of pain 1-10 on day 1 post operative
* time until walking
* number of Days until having bowel movement
* overall satisfactory

SECONDARY OUTCOMES:

* Operative time
* Estimated blood loss ( ebl ) - hemoglobin levels
* Hospital stay

Conditions

  • Cesarean Wound Repair

Interventions

PROCEDURE

Intra-abdominal repair

Intra abdominal repair of uterine incision

PROCEDURE

Extra-abdominal repair

Extra abdominal repair of uterine incision

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Elias Castel, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02373501 on ClinicalTrials.gov