Completed

NCT Number: NCT03298594

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

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.

Completed

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Key information

Conditions

Attempted Vaginal Delivery After a Cesarean Section

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

specific cervicograph

Diagnostic Test

Other names: usual cervicograph

Primary outcomes

Detection of dystocia during labor in women with past history of cesarean section

Time frame: From inclusion in the study (randomization usually from 2cm) until full cervical dilation.

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.

Secondary outcomes

Uterine rupture during labor in women with past history of cesarean section

Time frame: From inclusion in the study (randomization usually from 2cm) until delivery

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

Other outcomes

Percentage of VBAC

Time frame: at delivery

Percentage of vaginal delivery in women with past history of cesarean section

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Oct 2, 2017
Registry last updated: Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.