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Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial

Primary Purpose

Failure of Cervical Dilatation, Complications; Cesarean Section, Wound Infection,

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
cervix dilated after surgery
control group
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Failure of Cervical Dilatation focused on measuring Cervix Uteri, Cesarean Section, Infection, Dilatation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:Patients eligible for inclusion were those who had elective caesarean delivery. They had to be more than 37 weeks gestation.

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Exclusion Criteria:use of antibiotics during the last 24 h, pathology that should be treated with antibiotics, pre-existing maternal diseases, chorioamnionitis, fever on admission, need of transfusion before or during the caesarean section,ruptured membranes, emergency caesarean section and preterm caesarean section.

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Sites / Locations

  • Bakirkoy Dr Sadi Konuk Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cervix dilated after surgery

control group

Arm Description

Digital cervical dilatation performed by surgeon

cervix not dilated after surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Secondary outcomes that were analysed included wound infection, febrile morbidity and infectious morbidity.
Febrile morbidity was defined as a persistent fever of at least 38 celsius degree for at least 24 h after surgery and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere. Partial or total dehiscence or presence of purulent or serous wound discharge with induration, warmth and tenderness was considered as a wound infection. Endometritis was defined here as body temperature greater than 38.5 celsius degree with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination. A diagnosis of urinary tract infection was only considered when urinary symptoms associated with significant bacteruria (> 10.000.00 organisms/mL) on culture of midstream specimen of urine were noted. Blood loss was estimated using a drop in haemoglobin concentration within 24 h after the operation.

Full Information

First Posted
September 19, 2013
Last Updated
October 4, 2013
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01954719
Brief Title
Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial
Official Title
Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Participants with indication for elective caesarean section were randomly allocated to two groups. Group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation.Patients were randomised using computer-generated random numbers in sealed envelopes, to place them in one of the groups: group A (n = 200) women with intraoperative cervical dilatation; group B (n = 200) women with no intraoperative cervical dilatation. The investigator was not blinded to the procedure allocation. The allocated envelope was opened by the clinician just before the surgery. The procedure allocation was recorded in the women's charts.Antibiotic prophylaxis of 1 g of intravenous cefazolin or clindamycin 600 mg was given to each woman when the umbilical cord was clamped. In group 1 patients, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure of Cervical Dilatation, Complications; Cesarean Section, Wound Infection,, External Causes of Morbidity and Mortality
Keywords
Cervix Uteri, Cesarean Section, Infection, Dilatation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cervix dilated after surgery
Arm Type
Experimental
Arm Description
Digital cervical dilatation performed by surgeon
Arm Title
control group
Arm Type
No Intervention
Arm Description
cervix not dilated after surgery
Intervention Type
Procedure
Intervention Name(s)
cervix dilated after surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
control group
Intervention Description
surgeon not dilated cervix after surgery
Primary Outcome Measure Information:
Title
The primary outcome was rate of post-partum endometritis
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Secondary outcomes that were analysed included wound infection, febrile morbidity and infectious morbidity.
Description
Febrile morbidity was defined as a persistent fever of at least 38 celsius degree for at least 24 h after surgery and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere. Partial or total dehiscence or presence of purulent or serous wound discharge with induration, warmth and tenderness was considered as a wound infection. Endometritis was defined here as body temperature greater than 38.5 celsius degree with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination. A diagnosis of urinary tract infection was only considered when urinary symptoms associated with significant bacteruria (> 10.000.00 organisms/mL) on culture of midstream specimen of urine were noted. Blood loss was estimated using a drop in haemoglobin concentration within 24 h after the operation.
Time Frame
Febrile morbidity, blood loss and wound infection diagnosed at least 24 h after surgery
Other Pre-specified Outcome Measures:
Title
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.
Description
We hypothesised that routine intraoperative cervical dilatation during elective section in women receiving intravenous antibiotics would not significantly reduce post-partum maternal morbidities when compared with a similar group of women receiving intravenous antibiotics and no cervical dilatation at caesarean delivery.
Time Frame
24 h after surgery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients eligible for inclusion were those who had elective caesarean delivery. They had to be more than 37 weeks gestation. - Exclusion Criteria:use of antibiotics during the last 24 h, pathology that should be treated with antibiotics, pre-existing maternal diseases, chorioamnionitis, fever on admission, need of transfusion before or during the caesarean section,ruptured membranes, emergency caesarean section and preterm caesarean section. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hediye dağdeviren, md
Phone
5079872463
Email
hediyedagdeviren@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hüseyin cengiz, md
Organizational Affiliation
Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bakirkoy Dr Sadi Konuk Training and Research Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34140
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hediye dagdeviren, md
Phone
5079872463
Email
hediyedagdeviren@gmail.com
First Name & Middle Initial & Last Name & Degree
huseyin cengiz, md

12. IPD Sharing Statement

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Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial

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