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

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.

Study Overview

• Status: Terminated
• Conditions: Dystocia
• Intervention / Treatment: Other: Classical partograph; Other: New partograph based on the studies of Neal and Lowe

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

• Study Type: Interventional
• Enrollment (Actual): 633
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • University Strasbourg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Classical partograph; Classical partograph used as standard care
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Adrien GAUDINEAU, Strasbourg's University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2016
• Primary Completion (Actual): October 7, 2019
• Study Completion (Actual): October 7, 2019

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Dystocia
• Other Study ID Numbers: 6225