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

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Unknown

Conditions: External Causes of Morbidity and Mortality; Wound Infection,; Complications; Cesarean Section; Failure of Cervical Dilatation

Treatments: Procedure: control group; Procedure: cervix dilated after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01954719

2012-14-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

cervix dilated after surgery

Experimental group

Description:

Digital cervical dilatation performed by surgeon

Treatment:

Procedure: control group

Procedure: cervix dilated after surgery

control group

No Intervention group

Description:

cervix not dilated after surgery