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

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ClinicalTrials.gov Identifier: NCT01954719
Recruitment Status : Unknown
Verified September 2013 by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Recruitment status was:  Recruiting
First Posted : October 7, 2013
Last Update Posted : October 7, 2013
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

September 19, 2013
October 7, 2013
October 7, 2013
November 2012
December 2013   (Final data collection date for primary outcome measure)
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 ]
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.
Same as current
No Changes Posted
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 ]
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.
Same as current
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 ]
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.
Same as current
 
Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial
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
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Failure of Cervical Dilatation
  • Complications; Cesarean Section
  • Wound Infection,
  • External Causes of Morbidity and Mortality
  • 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
  • Experimental: cervix dilated after surgery
    Digital cervical dilatation performed by surgeon
    Interventions:
    • Procedure: cervix dilated after surgery
    • Procedure: control group
  • No Intervention: control group
    cervix not dilated after surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
January 2014
December 2013   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
 
NCT01954719
2012-14-06
No
Not Provided
Not Provided
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Not Provided
Study Director: hüseyin cengiz, md Bakırkoy Dr. Sadi Konuk Training and Research Hospital
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP