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

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01954719
• Other study ID #: 2012-14-06
• Status: Recruiting
• Phase: N/A
• First received: September 19, 2013
• Last updated: October 4, 2013
• Start date: November 2012
• Est. completion date: January 2014

Study information

• Verified date: September 2013
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: hediye dagdeviren, md
• Phone: 5079872463
• Email: hediyedagdeviren[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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.
• control group
surgeon not dilated cervix after surgery

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Training and Research Hospital	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No