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

NCT04935242 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3311

Last updated 2023-04-27

No results posted yet for this study

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

Sponsors & Collaborators

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Johan PACELLI · Fondation Hôpital Saint-Joseph

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2021-09-19
Completion
2022-04-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935242 on ClinicalTrials.gov