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

Study Overview
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Brief Summary
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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
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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

Conditions
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Dystocia

Intervention / Treatment
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* Other: New partograph based on the studies of Neal and Lowe
* Other: Classical partograph


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classical partograph<br>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<br>* Classical partograph used as standard care<br>|
| Experimental: New partograph<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section rate (all causes) |  | From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome | Total amount of oxytocin used (mUI) | 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 | Rate of uterine hyperstimulation (%) | 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 | Rate of post-partum hemorrhage (%) | 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 | Rate of uterine rupture (%) | 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 | Rate of retained placenta (%) | 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 | Need of an artificial rupture of membranes (Y/N) | 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 | Color of the amniotic fluid | 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 | Duration of the first and second stages of labour | 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 | Rate of vaginal delivery (spontaneous or assisted) (%) | 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 | Rate of cesarean section (according to indication) (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Maternal measures associated with possible effects of both strategies on maternal and fetal outcome | Need for an epidural or general anaesthesia | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Maternal measures associated with possible effects of both strategies on maternal and fetal outcome | Transfusion rate (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Maternal measures associated with possible effects of both strategies on maternal and fetal outcome | Maternal fever during labour (°C) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Maternal measures associated with possible effects of both strategies on maternal and fetal outcome | Rate of thrombo-embolic events (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Maternal measures associated with possible effects of both strategies on maternal and fetal outcome | Rate of third- and fourth-degree perineal tears and episiotomy (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Maternal measures associated with possible effects of both strategies on maternal and fetal outcome | Rate of surgical site infection, endometritis or septicemia (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Neonatal arterial umbilical cord pH < 7,00 and/or BD > 12 mmol/L | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Apgar score < 7 at 5 minutes | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Transfer to intensive care unit rate | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Neonatal infection rate (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Neonatal convulsion rate (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Rate of neonatal deaths (%) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) | 
| Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome | Neonatal encephalopathy rate (or the introduction of therapeutic hypothermia) | From the admission in the labour ward until the dismissal from maternity (2 to 5 days) |