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

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Dystocia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02741141

6225

Details and patient eligibility

About

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.

Full 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

Enrollment: 633 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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633 participants in 2 patient groups

Classical partograph

Active Comparator group

Description:

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.

Treatment:

Other: Classical partograph

New partograph

Experimental group

Description:

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.

Treatment:

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