Clinical trial NCT03298594: A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section
Official title: A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section: is the Management of Labor Improved?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attempted Vaginal Delivery After a Cesarean Section
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of dystocia during labor in women with past history of cesarean section
timeFrame: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.
Secondary outcomes:
measure: Uterine rupture during labor in women with past history of cesarean section
timeFrame: From inclusion in the study (randomization usually from 2cm) until delivery
Other outcomes:
measure: Percentage of VBAC
timeFrame: at delivery
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