Clinical trial NCT02741141: A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dystocia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: The main purpose of this study is to show a significant decrease of the CS rate with the use of the new partograph developed by Neal and Lowe.

Secondary purposes are

* To reduce the use of oxytocin during labour without increasing maternal or neonatal morbidity;
* To decrease immediate per-operative complications and post-operative complications associated with CS

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cesarean section rate (all causes)
timeFrame: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
Secondary outcomes:
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
measure: Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
timeFrame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Strasbourg Hospital
Study officials:
affiliation: Strasbourg's University Hospitals
name: Adrien GAUDINEAU
role: PRINCIPAL_INVESTIGATOR
References: