Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming

Launched by THE UNIVERSITY OF HONG KONG · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two methods, Propess and the Cook double-balloon catheter, to help prepare a woman’s cervix for labor when it isn’t ready. The goal is to see which method is more effective and safer for women who are at term in their pregnancy but have a cervix that is not yet ready for delivery. This trial is currently looking for participants who are healthy, pregnant with one baby, and are having their first child (nulliparous).

To be eligible, women must be at least 37 weeks pregnant and have a Bishop score of less than 7, which means their cervix is not yet favorable for labor. Participants in the trial will receive one of the two methods to help soften and open the cervix, making it easier for labor to start. It's important to note that women with certain medical conditions or previous surgeries may not qualify for this study. If you are interested in learning more about participating, it’s a good idea to talk to your healthcare provider.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Viable singleton pregnancy
• • Cephalic presentation
• • Bishop score \<7
• • At term (\>=37+0 weeks of gestation)
• • Nulliparous women
• Exclusion Criteria:
• • Gestation \<37weeks
• • Multiple pregnancy
• • Bishop score \<7
• • Malpresentation
• • Contraindication to vaginal delivery
• • Previous Caesarean section
• • History of myomectomy
• • Maternal fever
• • Suspected infection
• • Abnormal fetal heart-rate patterns
• • Rupture of membranes
• • Intrauterine growth restriction
• • Not fit for giving consent
• • Allergic to Propess or PGE2

Trial Officials