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Completed

NCT Number: NCT02373501

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

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

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Israel

About this study

Cesarean section (CS) delivery is one of the most frequent surgical procedures to be performed worldwide and rates of CS delivery are increasing. In the late 80's, the rate of caesarean deliveries was 10-13 % in most of the big hospitals in Israel, and today it reaches up to 20-25% of all deliveries.

Numerous different surgical techniques for caesarean section delivery have been described, and the debate about the optimal caesarean technique to minimize surgical morbidity is ongoing.

One of the more controversial issues regarding caesarean technique is the manner by which uterine repair is conducted after delivery of the infant(s) and placenta.

Two techniques are being used depending on the uterus position during repairmen : In situ within the peritoneal cavity (intra- abdominal repair) or temporarily exteriorized onto the mother's abdomen (extra- abdominal repair).

Arguments in favor of temporary exteriorization include better visualization of any uterine extensions and more rapid uterine repair with consequent reductions in both operative time and intraoperative blood loss. Opponents of extraabdominal repair argue that this technique increases rates of intraoperative nausea and vomiting, adnexal trauma on replacement, possible infection, and venous air embolism (VAE) .

On this study the investigators prospectively recruit women who are about to be electively operated. The patients will be randomized into two groups - extra- abdominal versus intra-abdominal uterine repair using computer randomization. Different charts will be for first CS delivery versus recurrent CS delivery. The patient won't know to which group she was designated . On day three after operation - she will be asked to fill out questionnaire with one of the investigators for subjective measurements

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • singleton pregnancy
  • term pregnancy

Exclusion criteria

  • chorioamnionitis
  • uterine rupture
  • hysterotomy - adhesiolysis

Treatment and study plan

Intra-abdominal repair

Procedure

Intra abdominal repair of uterine incision

Extra-abdominal repair

Procedure

Extra abdominal repair of uterine incision

Primary outcomes

  1. nausea and vomiting

    Time frame: during operation- 4 hours from anasthesia

  2. intraoperative hypotension

    Time frame: during operation- 4 hours from anasthesia

  3. intraoperative pain

    Time frame: during operation- 4 hours from anasthesia

  4. Blood transfusion

    Time frame: during operation- 4 hours from anasthesia

  5. Venous thromboembolism

    Time frame: durind operation - 4 hours from anasthesia

  6. Febrile Morbidity

    Time frame: post operative - untill release from hospitalization usually day 4

  7. Endometritis

    Time frame: post operative- untill release from hospitalization usually day 4

  8. Wound Infection

    Time frame: post operative- untill release from hospitalization usually day 4

  9. Death

    Time frame: post operative - untill release from hospitalization usually day 4

Secondary outcomes

  1. Operative time

    Time frame: operative time - since anasthesia untill closure of skin

  2. Estimated blood loss ( ebl ) - HGB levels

    Time frame: operative- 4 hours from anasthesia

  3. Hospital stay

    Time frame: post operative

Other outcomes

  1. complain of pain 1-10 on day 1 post operative

    Time frame: post operative - on day 3 post operative

  2. time from surgery until first walking

    Time frame: post operative - during hospitalization

  3. number of Days until having bowel movement,

    Time frame: post operative - during hospitalization

  4. overall satisfactory

    Time frame: post operative - during hospitalization

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Acronym: EKAM

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2015
Registry last updated
Dec 4, 2018

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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