Clinical trial NCT01954719: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Failure of Cervical Dilatation
Complications; Cesarean Section
Wound Infection,
External Causes of Morbidity and Mortality
Keywords: Cervix Uteri, Cesarean Section, Infection, Dilatation
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2013-10-07
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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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Primary outcomes:
measure: The primary outcome was rate of post-partum endometritis
timeFrame: 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:
measure: Secondary outcomes that were analysed included wound infection, febrile morbidity and infectious morbidity.
timeFrame: Febrile morbidity, blood loss and wound infection diagnosed at least 24 h after surgery
Other outcomes:
measure: 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.
timeFrame: 24 h after surgery
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Training and Research Hospital
state: Bakirkoy
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: hüseyin cengiz, md
role: STUDY_DIRECTOR
References: