Dystocia
Conditions
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
Interventions
OTHERNew partograph based on the studies of Neal and Lowe
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.
OTHERClassical partograph
Classical partograph used as standard care
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cesarean section rate (all causes) | From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Total amount of oxytocin used (mUI) |
| Maternal 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) | Need for an epidural or general anaesthesia |
| Neonatal 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) | Neonatal arterial umbilical cord pH \< 7,00 and/or BD \> 12 mmol/L |
Countries
France
Outcome results
None listed