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

A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section: is the Management of Labor Improved?

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.

Study Overview

• Status: Completed
• Conditions: Attempted Vaginal Delivery After a Cesarean Section
• Intervention / Treatment: Diagnostic test: specific cervicograph

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: specific cervicograph; Other Names: usual cervicograph
No Intervention: Usual cervicograph; The usual cervicograph in our unit is not having lines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of dystocia during labor in women with past history of cesarean section	Appropriate detection and management of dystocia by identifying women with: no progression of cervical dilation for more than 2 hours during labor; or slow progress, defined as a cervical dilation of less than 2 cm in 4 hours; and immediate decision of cesarean section, to be performed within 30 minutes.	From inclusion in the study (randomization usually from 2cm) until full cervical dilation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uterine rupture during labor in women with past history of cesarean section	Uterine rupture will be defined as a complete separation of the uterine scar that resulted in protrusion of fetal or placental parts in the peritoneal cavity	From inclusion in the study (randomization usually from 2cm) until delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of VBAC	Percentage of vaginal delivery in women with past history of cesarean section	at delivery

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2013
• Primary Completion (Actual): October 11, 2016
• Study Completion (Actual): October 11, 2016

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 12-173 MATPED 12-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No