Trials / Terminated
TerminatedNCT02741141
A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 633 (actual)
- Sponsor
- University Hospital, Strasbourg, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | Classical partograph | Classical partograph used as standard care |
Timeline
- Start date
- 2016-09-21
- Primary completion
- 2019-10-07
- Completion
- 2019-10-07
- First posted
- 2016-04-18
- Last updated
- 2021-10-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02741141. Inclusion in this directory is not an endorsement.