DystociaPARTODYSNCT02741141
A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
A study testing New partograph based on the studies of Neal and Lowe and Classical partograph in people with Dystocia, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystocia
- What is being tested?
- New partograph based on the studies of Neal and Lowe and Classical partograph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 633 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2016to 7 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Affiliation to a social security insurance
- Written consent given
- Singleton pregnancy
- Cephalic presentation
- ≥37 gestational weeks
- Spontaneous onset of labour
Who cannot join
- Previous cesarean section
- Induction of labour
- Intrauterine growth restriction
- In utero fetal death
- Congenital malformation
- Chorioamnionitis
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Dystocia
- Being tested
- New partograph based on the studies of Neal and Lowe, Classical partograph
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New partograph based on the studies of Neal and LoweOther
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 partographOther
Classical partograph used as standard care
| Study group | Role | What they receive |
|---|---|---|
| Classical partograph | Active comparator | 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. Receives: Other: Classical partograph |
| New partograph | Experimental | 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. Receives: Other: New partograph based on the studies of Neal and Lowe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section rate (all causes)
Measured: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
Secondary outcomes (23)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Total amount of oxytocin used (mUI)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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) (%)
Measured: 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) (%)
Measured: 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
Measured: 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 (%)
Measured: 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)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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)
Measured: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start21 Sep 2016
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Why it stopped: the study was stopped due to a change in delivery room practices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystociaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrien GAUDINEAU, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741141
- Sponsor's protocol ID
- 6225
- Acronym
- PARTODYS
- Status last verified
- Oct 2021
- First submitted
- 12 Jan 2016
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effect of Two Partographs on the Cesarean Section Rate in Women in Spontaneous Labour
- ClinicalTrials.gov ID
- NCT02741141
- Acronym / sponsor ID
- PARTODYS / 6225
- Conditions
- Dystocia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was stopped due to a change in delivery room practices
- Enrolment
- 633 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical partograph | Active comparator | Other: Classical partographLabour 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. |
| New partograph | Experimental | Other: New partograph based on the studies of Neal and LoweThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Affiliation to a social security insurance
- Written consent given
- Singleton pregnancy
- Cephalic presentation
Key exclusion criteria (11 listed)
- Previous cesarean section
- Induction of labour
- Intrauterine growth restriction
- In utero fetal death
- Congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New partograph based on the studies of Neal and LoweThe 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 | New partograph |
| Classical partographClassical partograph used as standard care | Other | Classical partograph |
Primary outcome
Cesarean section rate (all causes)
Time frame: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
23 secondary outcomes
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the admission in the labour ward until the dismissal from maternity (2 to 5 days)
Results and safety
The study was stopped early (reason given: the study was stopped due to a change in delivery room practices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Related trials for Dystocia
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Calcium Carbonate on Labor Induction
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Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
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Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrien GAUDINEAU principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New partograph based on the studies of Neal and Lowe and Classical partograph in people with Dystocia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the study was stopped due to a change in delivery room practices). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section rate (all causes) (time frame: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.