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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: cervix dilated after surgery
* Procedure: control group


Participation Criteria
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Eligibility Criteria
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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
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cervix dilated after surgery<br>Digital cervical dilatation performed by surgeon | Procedure: cervix dilated after surgery<br>* 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.<br>Procedure: control group<br>* surgeon not dilated cervix after surgery<br>|
| No Intervention: control group<br>cervix not dilated after surgery | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervix Uteri, Cesarean Section, Infection, Dilatation