Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014, France
NCT Number: NCT04935242
Syntocinon was granted marketing authorization in France in 1970. Since the 1960s, it has been frequently used during childbirth, particularly in cases of stagnation of cervical dilatation due to a lack of uterine contractility. According to the latest National Perinatal Survey of 2010, 66.5% of patients go into labor spontaneously and 58% of them receive Syntocinon during labor.
The reported maternal effects associated with the use of synthetic oxytocin include uterine hyperactivity, postpartum hemorrhage (PPH) and severe PPH. The administration of oxytocin increases the risk of uterine hyperactivity in a dose-dependent manner. Regarding fetal risk, the reported adverse effects concern fetal heart rate abnormalities related to uterine hyperactivity. However, no study has shown an association between oxytocin administration and excess neonatal morbidity and mortality, except in the subpopulation of patients with a scarred uterus.
Looking for future studies?
Notify Me18 year and older
Female
Observational
Paris, Île-de-France Region, 75014, France
In the 1950s, the speed of cervical dilation during labor was studied by Friedman. Dilatation is then divided into several phases:
Friedman concluded that cervical dilatation should be of the order of 1.5 cm/h and more in the active phase and that it should not fall below 1 cm/h in nulliparous women and 1.5 cm/h in multiparous women.
In the 1980s, the use of syntocinon became commonplace.Under the influence of an Irish physician, O'Driscoll, policies of quasi-systematic direction of labor were implemented, in particular in nulliparous women. This concept of active management of labor was developed in response to the observation of a high rate of cesarean sections performed for stagnation. This active labor management included systematic rupture of membranes (amniotomy) and infusion of Syntocinon when the dilation rate was less than 1 cm/h.
Beginning in the 2000s, Zhang also focused on the physiological duration of labor. He showed that a so-called normal labor could be much longer than previously described, especially before 6cm of cervical dilation. In 2010, he proposed a new partogram for nulliparous patients.
Finally, Neal performed a review of the literature in 2010, evaluating 7,009 low risk primiparous patients in spontaneous labor. He showed longer active phase durations than those described so far. The duration of labor at the 95th percentile was 13.4 hours and the average dilation rate around 0.6cm/h. The author concludes that a dilation speed of 0.5 cm/h can be tolerated in primiparous patients, without requiring additional intervention.
In this context, new French recommendations regarding oxytocin administration during spontaneous labor were published in December 2016. These recommendations were based mainly on studies including patients at term, without a history of cesarean section, with a single-fetal pregnancy and cephalic presentation:
These recommendations began to be applied in the maternity ward of Saint Joseph Hospital following their publication, starting in January 2017. These recommendations concern patients at low obstetrical risk, i.e., presenting a singleton pregnancy with a fetus estimated to be eutrophic and in cephalic presentation, a non-scarring uterus and spontaneous labor at term.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
Difference in management modalities between two groups of patients:
Time frame: Day 1
Difference in management modalities between two groups of patients:
Time frame: Day 1
Difference between these two groups of patients in terms of rate of vaginal delivery
Time frame: Day 1
Difference between these two groups of patients in terms of rate of postpartum hemorrhage
Time frame: Day 1
Difference between these two groups of patients in terms of rate of average APGAR scores in newborns measured at 1, 5 and 10 minutes of life
Fondation Hôpital Saint-Joseph
Other
Acronym: LAMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07566455
Female Urogenital Diseases and Pregnancy Complications, Hemorrhage
Multan, Punjab Province, Pakistan
View Trial DetailsNCT04760496
Body Weight, Nutrition Disorders
Angers, France
View Trial DetailsNCT05357521
Borderline Personality Disorder, Mental Disorders
Geneva, Canton of Geneva, Switzerland
View Trial DetailsNCT05823441
Agnosia, Analgesia
Beijing, Beijing Municipality, China
View Trial Details