Effect of Visceral and Parietal Peritoneum Suturation on Postoperative Vital Signs
1 other identifier
interventional
132
1 country
1
Brief Summary
In this study the investigators want to asses the effect of peritonisation at c-section on postoperative vital signs which was thought to be an indirect finding secondary to increased sympathetic activity originated from pain caused by stretched peritoneum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 postoperative-pain
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedOctober 20, 2015
October 1, 2015
7 months
September 16, 2015
October 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative vital sign (arterial tension)
First postoperative hour
Study Arms (4)
Only visceral peritoneum will be closed
EXPERIMENTALGroup1: Only visceral peritoneum will be closed
Only parietal peritoneum will be closed
EXPERIMENTALGroup 2: Only parietal peritoneum will be closed
Both of them will be closed
EXPERIMENTALGroup 3: Both of them will be closed
None of them will be closed
EXPERIMENTALGroup 4: None of them will be closed
Interventions
Eligibility Criteria
You may qualify if:
- Women underwent uncomplicated c-section
You may not qualify if:
- Patient with systemic Diseases
- Pregnant with Obstetric complications
- Pregnant with two or more previous c-sections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meryem Kurek EKEN
Istanbul, Üsküdar, 34280, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enis Özkaya, Assoc. Prof.
Zeynep Kamil Education and Research Hospital Obstetric and Gynecology Department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
September 16, 2015
First Posted
October 20, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2015
Study Completion
February 1, 2016
Last Updated
October 20, 2015
Record last verified: 2015-10