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

Attempted Vaginal Delivery After a Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298594
• Other study ID #: 12-173 MATPED 12-036
• Status: Completed
• Phase: N/A
• First received: September 26, 2017
• Last updated: September 29, 2017
• Start date: February 26, 2013
• Est. completion date: October 11, 2016

Study information

• Verified date: September 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 11, 2016
• Est. primary completion date: October 11, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Attempted Vaginal Delivery After a Cesarean Section

Intervention

Diagnostic Test:
• specific cervicograph

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of VBAC	Percentage of vaginal delivery in women with past history of cesarean section	at delivery
Primary	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	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