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NCT04935242: LAMA
Evaluation of the Modalities of Administration of Synthetic Oxytocin During Spontaneous Labor
trial in Oxytocin in 3,311 participants. Completed in 26 April 2022.
19 September 2021
Quick facts
| Lead sponsor | Fondation Hôpital Saint-Joseph |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 3,311 |
| Start date | 19 August 2021 |
| Primary completion | 19 September 2021 |
| Estimated completion | 26 April 2022 |
| Sites | 1 location across France |
Conditions studied
- Oxytocin — all drugs for Oxytocin →
Sponsor
Fondation Hôpital Saint-Joseph — full company profile →
Who can join
18 and older, female only, with Oxytocin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04935242
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Oxytocin
Currently open trials in the same condition.
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- NCT04551482 — Oxytocin for Weight Loss in Adolescents · Phase 2 · recruiting
Other Fondation Hôpital Saint-Joseph trials
Trials by the same sponsor.
- NCT07512960 — Duration of Dual Anti-Platelet Therapy in Chronic Limb Threatening Ischemia After Distal Revascularization · Phase 3 · not yet recruiting
- NCT07512908 — Study of Factors Influencing the Dynamics of Colonisation and Decolonisation of the Digestive Tract by Clostridioides Di · NA · not yet recruiting
- NCT07512830 — Evaluation of the Benefits of Hypnosis During Transoesophageal Echocardiography · NA · recruiting
- NCT07348081 — Real World Evidence to Assess the Value of a Digital Care Coordination and Monitoring Program for Supporting Caregivers · NA · recruiting
- NCT07086612 — Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and Transverse Orthodontic Deficiency in Children · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04935242 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondation Hôpital Saint-Joseph
- Last refreshed: 27 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04935242.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing