Back to resultsA Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour (PARTODYS)
Primary Purpose
Dystocia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
New partograph based on the studies of Neal and Lowe
Classical partograph
Sponsored by
About this trial
This is an interventional diagnostic trial for Dystocia
Eligibility Criteria
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
Sites / Locations
- University Strasbourg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Classical partograph
New partograph
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Cesarean section rate (all causes)
Secondary Outcome Measures
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Total amount of oxytocin used (mUI)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of uterine hyperstimulation (%)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of post-partum hemorrhage (%)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of uterine rupture (%)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of retained placenta (%)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Need of an artificial rupture of membranes (Y/N)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Color of the amniotic fluid
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Duration of the first and second stages of labour
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of vaginal delivery (spontaneous or assisted) (%)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of cesarean section (according to indication) (%)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Need for an epidural or general anaesthesia
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Transfusion rate (%)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Maternal fever during labour (°C)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of thrombo-embolic events (%)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of third- and fourth-degree perineal tears and episiotomy (%)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of surgical site infection, endometritis or septicemia (%)
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
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Apgar score < 7 at 5 minutes
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Transfer to intensive care unit rate
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Neonatal infection rate (%)
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Neonatal convulsion rate (%)
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Rate of neonatal deaths (%)
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Neonatal encephalopathy rate (or the introduction of therapeutic hypothermia)
Full Information
NCT ID
NCT02741141
First Posted
January 12, 2016
Last Updated
October 5, 2021
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02741141
Brief Title
A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
Acronym
PARTODYS
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
the study was stopped due to a change in delivery room practices
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
633 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classical partograph
Arm Type
Active Comparator
Arm Description
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.
Arm Title
New partograph
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
New partograph based on the studies of Neal and Lowe
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Classical partograph
Intervention Description
Classical partograph used as standard care
Primary Outcome Measure Information:
Title
Cesarean section rate (all causes)
Time Frame
From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
Secondary Outcome Measure Information:
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Total amount of oxytocin used (mUI)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of uterine hyperstimulation (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of post-partum hemorrhage (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of uterine rupture (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of retained placenta (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Need of an artificial rupture of membranes (Y/N)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Color of the amniotic fluid
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Duration of the first and second stages of labour
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of vaginal delivery (spontaneous or assisted) (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of cesarean section (according to indication) (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Need for an epidural or general anaesthesia
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Transfusion rate (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Maternal fever during labour (°C)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of thrombo-embolic events (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of third- and fourth-degree perineal tears and episiotomy (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of surgical site infection, endometritis or septicemia (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Neonatal arterial umbilical cord pH < 7,00 and/or BD > 12 mmol/L
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Apgar score < 7 at 5 minutes
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Transfer to intensive care unit rate
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Neonatal infection rate (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Neonatal convulsion rate (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Rate of neonatal deaths (%)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Title
Neonatal measures associated with possible effects of both strategies on maternal and fetal outcome
Description
Neonatal encephalopathy rate (or the introduction of therapeutic hypothermia)
Time Frame
From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrien GAUDINEAU
Organizational Affiliation
Strasbourg's University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Strasbourg Hospital
City
Strasbourg
ZIP/Postal Code
67098
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
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