Clinical Trials Directory

Trials / Completed

CompletedNCT03298594

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?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
135 (actual)
Sponsor
University Hospital, Geneva · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTspecific cervicograph

Timeline

Start date
2013-02-26
Primary completion
2016-10-11
Completion
2016-10-11
First posted
2017-10-02
Last updated
2017-10-02

Source: ClinicalTrials.gov record NCT03298594. Inclusion in this directory is not an endorsement.