A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
- Conditions
- Dystocia
- Interventions
- Other: Classical partographOther: New partograph based on the studies of Neal and Lowe
- Registration Number
- NCT02741141
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 633
Age ≥ 18 years
- Affiliation to a social security insurance
- Written consent given
- Singleton pregnancy
- Cephalic presentation
- ≥37 gestational weeks
- Spontaneous onset of labour
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Classical partograph Classical partograph 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. New partograph New partograph based on the studies of Neal and Lowe 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.
- Primary Outcome Measures
Name Time Method Cesarean section rate (all causes) From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
- Secondary Outcome Measures
Name Time Method 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) Rate of cesarean section (according to indication) (%)
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) Rate of surgical site infection, endometritis or septicemia (%)
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 encephalopathy rate (or the introduction of therapeutic hypothermia)
Trial Locations
- Locations (1)
University Strasbourg Hospital
🇫🇷Strasbourg, France