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

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

Study Overview

• Status: Unknown
• Conditions: External Causes of Morbidity and Mortality; Complications; Cesarean Section; Failure of Cervical Dilatation; Wound Infection,
• Intervention / Treatment: Procedure: cervix dilated after surgery; Procedure: control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bakirkoy
    • Istanbul, Bakirkoy, Turkey, 34140
      • Recruiting
      • Bakirkoy Dr Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Febrile morbidity, blood loss and wound infection diagnosed at least 24 h after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 h after surgery

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: September 19, 2013
• First Submitted That Met QC Criteria: October 4, 2013
• First Posted (ESTIMATE): October 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2013
• Last Update Submitted That Met QC Criteria: October 4, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Cervix Uteri, Cesarean Section, Infection, Dilatation
• Additional Relevant MeSH Terms: Infections; Pathological Conditions, Anatomical; Wound Infection; Dilatation, Pathologic
• Other Study ID Numbers: 2012-14-06