Evaluation of the Modalities of Administration of Synthetic Oxytocin During Spontaneous Labor

NCT04935242 | Completed

• 1 other identifier: LAMA (LAbour Management)
• Study Type: observational
• Target: 3,311
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxytocin

Outcome Measures

Primary Outcomes (2)

• Assessment of professional practices before the recommendations for clinical practice (RPC) published in December 2016, concerning the modalities of administration of synthetic oxytocin during physiological labor

  Difference in management modalities between two groups of patients: * A first group of patients who gave birth in 2016 * A second group of patients who gave birth in 2018

  Day 1

• Assessment of professional practices after the recommendations for clinical practice (RPC) published in December 2016, concerning the modalities of administration of synthetic oxytocin during physiological labor

  Difference in management modalities between two groups of patients: * A first group of patients who gave birth in 2016 * A second group of patients who gave birth in 2018

  Day 1

Secondary Outcomes (3)

• Evaluation of the impact of the application of the new recommendations on the rate of vaginal deliveries

  Day 1

• Evaluation of the impact of the application of the new recommendations on the rate of postpartum hemorrhage

  Day 1

• Evaluation of the impact of the application of the new recommendations on the rate of neonatal morbidity

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who delivered at Paris Saint Joseph Hospital in 2016 and 2018

You may qualify if:

• Major patient
• Single pregnancy
• Non-scarring uterus
• Fetus estimated to be eutrophic in prenatal
• Cephalic presentation
• Spontaneous labor from 37 weeks of amenorrhea

You may not qualify if:

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient objecting to the use of her data for this research

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

• Johan PACELLI

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 22, 2021
• Study Start: August 19, 2021
• Primary Completion: September 19, 2021
• Study Completion: April 26, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)