NCT02479932

Brief Summary

The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 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

June 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

June 11, 2015

Last Update Submit

March 14, 2016

Conditions

Labor Pain

Keywords

Extra-peritoneal cesareanIntra-peritoneal cesarean

Outcome Measures

Primary Outcomes (1)

  • Skin-to-delivery time

    1 minute after delivery

Secondary Outcomes (11)

  • Postoperative pain

    24 and 48 hour after cesarean

  • Operation time

    Two minutes after surgery

  • Hemoglobin differences

    One hour before cesarean and 48 hours after cesarean

  • Need for analgesic

    24 and 48 hours after cesarean

  • Nausea

    Two minutes and 48 hours after cesarean

  • +6 more secondary outcomes

Study Arms (2)

Extraperitoneal cesarean

ACTIVE COMPARATOR
Other: Extraperitoneal cesarean technique

Transperitoneal cesarean

ACTIVE COMPARATOR
Other: Transperitoneal cesarean technique

Interventions

Transperitoneal cesarean techniqueOTHER

Pfannenstiel-Kerr technique for laparatomy and uterine entry

Transperitoneal cesarean
Extraperitoneal cesarean techniqueOTHER

Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry

Extraperitoneal cesarean

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • elective cesarean
  • previous cesarean (\<4)
  • cesarean for distocia

You may not qualify if:

  • emergency cesarean ( fetal distress)
  • risk of obstetrical bleeding
  • maternal coagulation defects
  • adnexial mass
  • uterin myoma at incision site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yunus E TOPDAGI, MD

    Ataturk University

    PRINCIPAL INVESTIGATOR

  • Omer E Yapca, MD

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 24, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Locations

TU(1)