NCT02373501

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

5.9 years

First QC Date

July 29, 2013

Last Update Submit

December 2, 2018

Conditions

Cesarean Wound Repair

Keywords

caesarean deliveryuterine incision repair

Outcome Measures

Primary Outcomes (9)

  • nausea and vomiting

    during operation- 4 hours from anasthesia

  • intraoperative hypotension

    during operation- 4 hours from anasthesia

  • intraoperative pain

    during operation- 4 hours from anasthesia

  • Blood transfusion

    during operation- 4 hours from anasthesia

  • Venous thromboembolism

    durind operation - 4 hours from anasthesia

  • Febrile Morbidity

    post operative - untill release from hospitalization usually day 4

  • Endometritis

    post operative- untill release from hospitalization usually day 4

  • Wound Infection

    post operative- untill release from hospitalization usually day 4

  • Death

    post operative - untill release from hospitalization usually day 4

Secondary Outcomes (3)

  • Operative time

    operative time - since anasthesia untill closure of skin

  • Estimated blood loss ( ebl ) - HGB levels

    operative- 4 hours from anasthesia

  • Hospital stay

    post operative

Other Outcomes (4)

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

    post operative - on day 3 post operative

  • time from surgery until first walking

    post operative - during hospitalization

  • number of Days until having bowel movement,

    post operative - during hospitalization

  • +1 more other outcomes

Study Arms (2)

intra-abdominal repair

EXPERIMENTAL

intra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.

Procedure: Intra-abdominal repair

extra-abdominal repair

EXPERIMENTAL

extra-abdominal repair of uterine incision, after delivery of the fetus and the placenta.

Procedure: Extra-abdominal repair

Interventions

Intra-abdominal repairPROCEDURE

Intra abdominal repair of uterine incision

intra-abdominal repair
Extra-abdominal repairPROCEDURE

Extra abdominal repair of uterine incision

extra-abdominal repair

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy
  • term pregnancy

You may not qualify if:

  • chorioamnionitis
  • uterine rupture
  • hysterotomy - adhesiolysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (1)

  • Jacob CE, Pasquier JC. Extraabdominal vs intraabdominal uterine repair at cesarean delivery: a metaanalysis. Am J Obstet Gynecol. 2010 Apr;202(4):e10-1; author reply e11. doi: 10.1016/j.ajog.2009.10.879. Epub 2009 Dec 22. No abstract available.

    PMID: 20022585BACKGROUND

Study Officials

  • Elias Castel, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Elias Castel

Study Record Dates

First Submitted

July 29, 2013

First Posted

February 27, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

IL(1)