An interventional study of New partograph based on the studies of Neal and Lowe and Classical partograph in Dystocia, sponsored by University Hospital, Strasbourg, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-14.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic
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.
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
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 633 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Classical partograph used as standard care
Cesarean section rate (all causes)
Time frame: From admission in the labour ward to the delivery (duration from 0 to 24 hours approximately)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Total amount of oxytocin used (mUI)
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
Rate of uterine hyperstimulation (%)
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
Rate of post-partum hemorrhage (%)
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
Rate of uterine rupture (%)
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
Rate of retained placenta (%)
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
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)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
Color of the amniotic fluid
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
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)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
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)
obstetrical measures associated with possible effects of both strategies on maternal and fetal outcome
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)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
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)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
Transfusion rate (%)
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
Maternal fever during labour (°C)
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
Rate of thrombo-embolic events (%)
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
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)
Maternal measures associated with possible effects of both strategies on maternal and fetal outcome
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)
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
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
Apgar score \< 7 at 5 minutes
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
Transfer to intensive care unit rate
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
Neonatal infection rate (%)
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
Neonatal convulsion rate (%)
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
Rate of neonatal deaths (%)
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
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)
Ran from Sep 2016 to primary completion in Oct 2019, 36 months.
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This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →