Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening

Launched by UNIVERSITY HOSPITAL, TOURS · Jun 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best way to help women with an unfavorable cervix (which means their cervix isn’t ready for labor) after they have undergone 24 hours of cervical ripening, a procedure used to prepare the cervix for labor. The trial will compare two methods: using a medication called oxytocin to start labor versus continuing the cervical ripening process with another medication called prostaglandins. The goal is to find out which approach leads to safer deliveries and greater satisfaction for mothers, while also reducing the chances of needing a cesarean delivery.

To participate in this study, women must be at least 18 years old, pregnant with a single baby, and between 37 and 42 weeks into their pregnancy. They should have already undergone 24 hours of cervical ripening and have an unfavorable cervix, as indicated by a specific scoring system. If you join this trial, you’ll either receive oxytocin to induce labor or continue with cervical ripening. The trial is currently recruiting participants and aims to help improve the experience and outcomes for women during labor induction.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant woman
• • ≥ 18 years old
• • With a singleton cephalic pregnancy
• • Between ≥37+0 weeks and ≤ 42+0 weeks of gestation
• • Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation)
• • With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours
• • Bishop score ≤ 6 at inclusion (unfavorable cervix)
• • French health insurance policy holder
• • Written informed consent
• Exclusion Criteria:
• • Any measures of legal protection
• • Prior caesarean section or uterine scar
• • Contra-indications to a vaginal delivery
• • Foetus with suspected severe congenital abnormalities
• • Pathological foetal heart rate
• • Contra-indications to ANGUSTA® (oral misoprostol, cervical ripening agent)
• • Contra-indications to PROPESS® (vaginal slow releasing system of dinoprostone, cervical ripening agent)
• • Contra-indications to PROSTINE® (vaginal gel of dinoprostone, cervical ripening agent)
• • Contra-indications for using oxytocin
• • Woman in labor or with more than 3 contractions / 10 minutes