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

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

Recruiting
18-50 years
Female
Phase 4

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Overview

The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.

Description

Previous studies focused on use of PGE2 instead of Propess, which is a preparation of PGE2 packaged in a hydrogel polymer matrix and release 10mg dinoprostone at 0.3mg per hour for 24 hours. Compared with PGE2, Propess can achieve a shorter induction-to-birth interval, a higher rate of vaginal delivery within 24 hours, and a smaller number of vaginal examinations during delivery. However local studies comparing the efficacy and satisfaction of cervical priming between Cook double-balloon catheter and Propess were lacking. The investigators aimed to compare efficacy and safety of Propess versus Cooks double-balloon catheter for cervical ripening with an unfavorable cervix in term pregnancy.

Eligibility

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

Study details
    Delivery Problem

NCT06438081

The University of Hong Kong

15 October 2025

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