Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 19, 2013
CompletedFirst Posted
Study publicly available on registry
October 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedOctober 7, 2013
September 1, 2013
1.1 years
September 19, 2013
October 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome was rate of post-partum endometritis
The post-partum care for both groups was identical, and included vital signs every four hours, discontinuation of the Foley catheter and advancement of diet on the first postoperative day. All patients in both groups were observed daily in order to assess the following variables: any sign of wound infection (erythema, swelling, discharge or tenderness), vaginal discharge, uterine consistency and height and peritoneal reaction for peritonitis. Clinical signs of urinary tract infection were checked, and urinalysis was performed. A complete blood count was assessed 24 h after delivery. The patients were discharged on third postoperative day if there was no infection or complication.
All patients in both groups were observed daily,blood count was assessed 24 h after delivery and the patients were discharged on third postoperative day if there was no infection or complication
Secondary Outcomes (1)
Secondary outcomes that were analysed included wound infection, febrile morbidity and infectious morbidity.
Febrile morbidity, blood loss and wound infection diagnosed at least 24 h after surgery
Other Outcomes (1)
After elective cesarean section routine cervical dilatation is necessary? Change in post-partum maternal morbidities when compared with a similar group of women receiving intravenous antibiotics and no cervical dilatation at caesarean delivery.
24 h after surgery
Study Arms (2)
cervix dilated after surgery
EXPERIMENTALDigital cervical dilatation performed by surgeon
control group
NO INTERVENTIONcervix not dilated after surgery
Interventions
The surgeon inserted his or her double-gloved index digit in the cervical canal to dilate it and removed the outer gloves after digital dilatation of the cervix.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, Bakirkoy, 34140, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
hüseyin cengiz, md
Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2013
First Posted
October 7, 2013
Study Start
November 1, 2012
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
October 7, 2013
Record last verified: 2013-09