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

NCT ID: NCT01954719

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-01-31

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.

Conditions

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

Keywords

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Cervix Uteri, Cesarean Section, Infection, Dilatation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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cervix dilated after surgery

Digital cervical dilatation performed by surgeon

Group Type EXPERIMENTAL

cervix dilated after surgery

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

surgeon not dilated cervix after surgery

control group

cervix not dilated after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

control group

surgeon not dilated cervix after surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hüseyin cengiz, md

Role: STUDY_DIRECTOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

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Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Bakirkoy, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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hediye dağdeviren, md

Role: CONTACT

Phone: 5079872463

Email: [email protected]

Facility Contacts

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hediye dagdeviren, md

Role: primary

Other Identifiers

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2012-14-06

Identifier Type: -

Identifier Source: org_study_id