A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
NCT ID: NCT02741141
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
633 participants
INTERVENTIONAL
2016-09-21
2019-10-07
Brief Summary
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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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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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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
Classical partograph
Classical partograph used as standard care
New partograph
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.
New 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.
Interventions
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New 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.
Classical partograph
Classical partograph used as standard care
Eligibility Criteria
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Inclusion Criteria
* Affiliation to a social security insurance
* Written consent given
* Singleton pregnancy
* Cephalic presentation
* ≥37 gestational weeks
* Spontaneous onset of labour
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Adrien GAUDINEAU
Role: PRINCIPAL_INVESTIGATOR
Strasbourg's University Hospitals
Locations
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University Strasbourg Hospital
Strasbourg, , France
Countries
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Other Identifiers
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6225
Identifier Type: -
Identifier Source: org_study_id