NCT02760290

Brief Summary

Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 14, 2016

Last Update Submit

March 13, 2022

Conditions

Postpartum FeverIleusHemorrhagePain

Keywords

Forced Expiratory Volume in 1 secondForced expiratory vital capacityPeak expiratory flow

Outcome Measures

Primary Outcomes (1)

  • Pain Scores as measured by the Visual Analog Scale

    2 days

Secondary Outcomes (7)

  • Blood count

    2 days

  • C reactive proteins level

    2 days

  • Complications

    2 days

  • Discharge time

    4 days

  • Forced expiratory volume in 1 second

    2 days

  • +2 more secondary outcomes

Study Arms (2)

Extraperitoneal group

EXPERIMENTAL

Extraperitoneal cesarean section will perform after rectus sheat incision and carefully bladder dissecting.

Procedure: Extraperitoneal cesarean section

Intraperitoneal group

ACTIVE COMPARATOR

Conventional transperitoneal cesarean will perform

Procedure: Intraperitoneal cesarean section

Interventions

Extraperitoneal cesarean sectionPROCEDURE
Extraperitoneal group
Intraperitoneal cesarean sectionPROCEDURE
Intraperitoneal group

Eligibility Criteria

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

You may qualify if:

  • Cesarean section for any reasons

You may not qualify if:

  • Involuntary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (2)

  • Tappauf C, Schest E, Reif P, Lang U, Tamussino K, Schoell W. Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity. Am J Obstet Gynecol. 2013 Oct;209(4):338.e1-8. doi: 10.1016/j.ajog.2013.05.057. Epub 2013 May 30.

    PMID: 23727518RESULT

  • Chou CY, Liang PC, Chen CA, Lee CN. Cervical abscess with vaginal fistula after extraperitoneal Cesarean section. J Formos Med Assoc. 2007 Dec;106(12):1048-51. doi: 10.1016/S0929-6646(08)60082-0.

    PMID: 18194912RESULT

Related Links

MeSH Terms

Conditions

Puerperal InfectionIleusHemorrhagePain

Condition Hierarchy (Ancestors)

Pregnancy Complications, InfectiousInfectionsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mehmet Baki Şentürk, MD

    Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pirincipal investigator

Study Record Dates

First Submitted

March 14, 2016

First Posted

May 3, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

TU(1)