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A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section

NCT ID: NCT03298594

Last Updated: 2017-10-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-26

Study Completion Date

2016-10-11

Brief Summary

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The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to this specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines). The primary outcome is appropriate detection of dystocia.

Detailed Description

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Appropriate management of labor is essential to minimize the risk of uterine rupture in case of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk factor for uterine rupture during labor in women with previous cesarean section. Some studies have shown that this risk increases after 2 hours at the same cervical dilation during labor. The cervicograph is an important tool to detect dystocia during labor. There is currently no specific cervicograph for pregnant women with a history of cesarean section, and no study evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.

The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to a specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines).

The outcomes of this randomized trial are: appropriate detection and management of dystocia; uterine rupture; and success of VBAC.

Conditions

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Attempted Vaginal Delivery After a Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The cervicograph of all participants will be reviewed by two assessors blinded to the study group. In order to be blinded, lines will be added to the cervicographs of the control group by a third party not involved in the evaluation

Study Groups

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specific cervicograph

Specific cervicograph, including an alert line (normal progression of cervical dilation, i.e. 1 cm per hour) and an action line 2 hours after the alert line. This should be completed after the diagnose of active labor

Group Type EXPERIMENTAL

specific cervicograph

Intervention Type DIAGNOSTIC_TEST

Usual cervicograph

The usual cervicograph in our unit is not having lines

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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specific cervicograph

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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usual cervicograph

Eligibility Criteria

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Inclusion Criteria

* Women in labor, admitted for a VBAC at a gestational age of 37 weeks or more
* Single pregnancy
* Cephalic presentation

Exclusion Criteria

* More than 1 previous cesarean section
* Multiple pregnancies
* Presentations other than cephalic
* History of low vertical uterotomy, classical or inverted T-shaped
* Past history of myomectomy
* Fetal death
* Fetal anomalies
* Placental anomalies
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Michel Boulvain

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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12-173 MATPED 12-036

Identifier Type: -

Identifier Source: org_study_id