Using Oxytocin before Planned Caesarean Sections
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial
This study is testing if giving oxytocin before planned C-sections can help newborns breathe better and improve their bonding and breastfeeding with mothers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1450 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Zurich Academic / other |
| Locations | 5 sites (Zurich, ZH and 4 other locations) |
| Trial ID | NCT03693885 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of administering oxytocin prior to planned caesarean sections to enhance neonatal outcomes. By triggering uterine contractions, the researchers hope to reduce respiratory issues in newborns and improve bonding and breastfeeding success. The study is designed as an open-label, randomized, placebo-controlled trial, focusing on singleton pregnancies over 34 weeks without prior labor. Additionally, it will collect weight data of infants in the first six months to validate a neonatal weight calculator.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals with a singleton pregnancy over 34 weeks scheduled for a primary caesarean section without prior contractions.
Not a fit: Patients with chromosomal aberrations, malformations, or other serious maternal or fetal health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve neonatal health and breastfeeding rates for infants delivered via caesarean section.
How similar studies have performed: While the specific approach of using oxytocin in this context is novel, similar studies have shown promising results in improving neonatal outcomes with labor induction techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton pregnancy \>34 weeks * primary caesarean section, that is without preceding contractions or rupture of the membranes, * absence of a contraindication to oxytocin Exclusion Criteria: * Chromosomal aberration * malformation, * IUGR, * Nonreassuring fetal heart rate pattern, * Placenta praevia, * maternal substance abuse, * infections, * hypertension, * preeclampsia, * diabetes type I or II, * autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.), * renal disease, * history of more than one previous caesarean section.
Where this trial is running
Zurich, ZH and 4 other locations
- University Hospital Zurich, Department of Obstetrics — Zurich, Zh, Switzerland (Recruiting)
- Baden Cantonal Hospital — Baden, Switzerland (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Saint Gallen Cantonal Hospital — Saint Gallen, Switzerland (Recruiting)
- Winterthur Cantonal Hospital — Winterthur, Switzerland (Recruiting)
Study contacts
- Principal investigator: Tilo Burkhardt, MD — Dept. of Obstetrics, University Hospital Zurich
- Study coordinator: Tilo Burkhardt, MD
- Email: tilo.burkhardt@usz.ch
- Phone: +41 44 255 5192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.