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

This study is currently recruiting participants.
Verified September 2013 by Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01954719
First received: September 19, 2013
Last updated: October 4, 2013
Last verified: September 2013
  Purpose

The purpose of this prospective randomised study was to determine the effect of routine cervical dilatation during elective caesarean section on maternal morbidity


Condition Intervention
Failure of Cervical Dilatation
Complications; Cesarean Section
Wound Infection,
External Causes of Morbidity and Mortality
Procedure: cervix dilated after surgery
Procedure: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • The primary outcome was rate of post-partum endometritis [ 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Febrile morbidity, blood loss and wound infection diagnosed at least 24 h after surgery ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • 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. [ Time Frame: 24 h after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cervix dilated after surgery
Digital cervical dilatation performed by surgeon
Procedure: cervix dilated after surgery
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.
Procedure: control group
surgeon not dilated cervix after surgery
No Intervention: control group
cervix not dilated after surgery

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01954719

Contacts
Contact: hediye dağdeviren, md 5079872463 hediyedagdeviren@gmail.com

Locations
Turkey
Bakirkoy Dr Sadi Konuk Training and Research Hospital Recruiting
Istanbul, Bakirkoy, Turkey, 34140
Contact: hediye dagdeviren, md    5079872463    hediyedagdeviren@gmail.com   
Principal Investigator: huseyin cengiz, md         
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
Study Director: hüseyin cengiz, md bakirkoy dr sadi konuk training and research hospital
  More Information

No publications provided

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01954719     History of Changes
Other Study ID Numbers: 2012-14-06
Study First Received: September 19, 2013
Last Updated: October 4, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
Cervix Uteri, Cesarean Section, Infection, Dilatation

Additional relevant MeSH terms:
Dilatation, Pathologic
Wound Infection
Pathological Conditions, Anatomical
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014