Comparing two methods for cervical priming in pregnant women
Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial
This study is testing whether a medication called Propess or a special balloon catheter works better and safer for preparing the cervix in pregnant women who are close to their due date.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06438081 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of Propess, a PGE2 preparation, against the Cook double-balloon catheter for cervical ripening in women with an unfavorable cervix at term. The research focuses on how these two methods affect the induction-to-birth interval, rates of vaginal delivery within 24 hours, and the number of vaginal examinations required during delivery. By addressing the lack of local studies on this comparison, the investigators hope to provide valuable insights into the best practices for cervical priming in term pregnancies.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women with a viable singleton pregnancy, cephalic presentation, and a Bishop score of less than 7 at term.
Not a fit: Patients who are not suitable for vaginal delivery or have contraindications such as previous Caesarean sections or multiple pregnancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for cervical ripening, resulting in better delivery outcomes for women.
How similar studies have performed: While previous studies have examined PGE2, local comparisons between Propess and the Cook double-balloon catheter are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Yin Fong Leung, MBBS — The University of Hong Kong
- Study coordinator: Yin Fong Leung, MBBS
- Email: lyf971@hku.hk
- Phone: 852 22554517
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.