RecruitingPhase 4NCT06438081

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

Comparison Between Propess (Dinoprostone Controlled Release Pessary) and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial


Sponsor

The University of Hong Kong

Enrollment

28 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria5

  • Viable singleton pregnancy
  • Cephalic presentation
  • Bishop score \<7
  • At term (\>=37+0 weeks of gestation)
  • Nulliparous women

Exclusion Criteria14

  • 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

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Interventions

COMBINATION_PRODUCTCook double-balloon catheter

To compare whether Cook double-balloon catheter or Propess able to achieve vaginal delivery with a shorter priming to delivery interval


Locations(1)

Queen Mary Hospital

Hong Kong, Hong Kong

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NCT06438081


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