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

Dystocia Clinical Trial

— PARTODYS  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02741141
• Other study ID #: 6225
• Status: Terminated
• Phase: N/A
• Start date: September 21, 2016
• Est. completion date: October 7, 2019

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 633
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystocia

Intervention

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.
• Classical partograph
Classical partograph used as standard care

Locations

Country	Name	City	State
France	University Strasbourg Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean section rate (all causes)		From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)