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

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Attempted Vaginal Delivery After a Cesarean Section

Treatments

Diagnostic Test: specific cervicograph

Study type

Interventional

Funder types

Other

Identifiers

NCT03298594
12-173 MATPED 12-036

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

135 participants in 2 patient groups

specific cervicograph
Experimental group
Description:
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
Treatment:
Diagnostic Test: specific cervicograph
Usual cervicograph
No Intervention group
Description:
The usual cervicograph in our unit is not having lines

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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