A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour

NCT02741141 | Terminated

• 1 other identifier: 6225
• Study Type: interventional
• Target: 633
• Locations: 1 country
• Sites: 1

Brief Summary

In the 2010-french perinatal survey, the overall cesarean section (CS) rate during labour was 21 % and 16% to 38% in case of dystocia. The definition of " dystocia " is traditionally based on the research led by Friedman in the 1950's on a restricted population sample. Several studies over the last years seem to indicate that the different phases of labour are longer than originally described by Friedman. Our current hypothesis is that the application of a new definition of dystocia would enable a more appropriate management of labour.

Conditions

Dystocia

Outcome Measures

Primary Outcomes (1)

• Cesarean section rate (all causes)

  From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)

Secondary Outcomes (23)

• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome

  From the admission in the labour ward until the dismissal from maternity (2 to 5 days)

• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome

  From the admission in the labour ward until the dismissal from maternity (2 to 5 days)

• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome

  From the admission in the labour ward until the dismissal from maternity (2 to 5 days)

• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome

  From the admission in the labour ward until the dismissal from maternity (2 to 5 days)

• obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome

  From the admission in the labour ward until the dismissal from maternity (2 to 5 days)

Study Arms (2)

Classical partograph

ACTIVE COMPARATOR

Labour dystocia is diagnosed when cervical dilation is less than 1 cm per hour or after 3 hours at complete cervical dilation without engagement of the presentation. In this case, active management of labour is started with introduction of oxytocin, artificial rupture of membranes and supportive therapy.

Other: Classical partograph

New partograph

EXPERIMENTAL

The second strategy is based on the partograph developped by Neal and Lowe. An active management of labour is started when crossing the dystocia line or when there are no cervical modifications after 4 hours beyond 5 cm of cervical dilation. In this case, active management of labour is started with introduction of oxytocin, artificial rupture of membranes and supportive therapy.

Other: New partograph based on the studies of Neal and Lowe

Interventions

New partograph based on the studies of Neal and Lowe OTHER

The partograph designed by Neal and Lowe includes an "action line" which if crossed permits an active management of labour. Eventually, the only difference between the two arms is the moment when the active management of labour is started. The oxytocin is administrated according to the department protocol.

New partograph

Classical partograph OTHER

Classical partograph used as standard care

Classical partograph

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Affiliation to a social security insurance
• Written consent given
• Singleton pregnancy
• Cephalic presentation
• ≥37 gestational weeks
• Spontaneous onset of labour

You may not qualify if:

• Previous cesarean section
• Induction of labour
• Intrauterine growth restriction
• In utero fetal death
• Congenital malformation
• Chorioamnionitis
• Placenta praevia
• Need for an emergency delivery (fetal heart rate abnormalities at admission)
• Contra-indication for vaginal delivery
• Patient under temporary guardianship, guardianship or judicial protection
• Patient included in another study which could interfere with the results of this study

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

University Strasbourg Hospital

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Adrien GAUDINEAU

  Strasbourg's University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: April 18, 2016
• Study Start: September 21, 2016
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

FR (1)