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

NCT06438081 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: UW 24-172
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delivery Problem

Outcome Measures

Primary Outcomes (1)

• Priming to delivery interval

  Time for priming (device placement) to delivery interval

  1 year

Secondary Outcomes (13)

• Vaginal delivery within 24 hours after priming

  1 year

• Caesarean section rate

  1 year

• Vaginal delivery rate

  1 year

• Priming to induction interval

  1 year

• Need of induction with oxytocin

  1 year

Study Arms (2)

Cook double-balloon catheter

ACTIVE COMPARATOR

Participant is placed in lithotomy position, then to clean vulval and vaginal area, followed by inserting vaginal speculum. Cook double-balloon catheter will be inserted under standard technique. Doctor or midwife guide the cervical ripening balloon with stylet to pass through the cervix. Uterine balloon should be place above level of internal os, then to remove the stylet before further advancing the catheter. Cook double-balloon catheter is further advancing through the cervix until both balloons entered cervical canal. Uterine and vaginal balloons are both inflated with up to 80ml normal saline according to manufacturer recommendation. Maximal duration of balloon placement will be 12 hours. If cervix remains unfavorable after Cook double-catheter balloons, she will be given another Cook double-catheter balloons priming the next day. If cervix remains unfavourable after two balloon priming, elective Caesarean section will be advised.

Combination Product: Cook double-balloon catheter

Propess

PLACEBO COMPARATOR

Participant will be firstly confirmed reactive tracing and without regular contraction by non-stress test for 20mins. Propess will be checked its integrity and applied with lubricating jelly before insertion. Propess is inserted to the posterior vaginal fornix. Woman should inform medical staff if they have leaking sensation. After insertion, woman will be advised to lie down and perform non-stress test for 2 hours. Propess will be removed after 24 hours post insertion. Cervical assessment is performed the next day after removal of Propess. Patient with favourable cervix, i.e. Bishop score \>= 7, will start artificial rupture of membrane and syntocinon infusion. Patient with unfavorable cervix, i.e. Bishop score \<7 is arranged another day of priming by PGE2. If the cervix remains unfavorable after 2 days of pharmacological priming, women will be given a rest day or continued priming by Cook double-balloon catheter.

Combination Product: Cook double-balloon catheter

Interventions

Cook double-balloon catheter COMBINATION_PRODUCT

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

Cook double-balloon catheter; Propess

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Yin Fong Leung, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin Fong Leung, MBBS

CONTACT

852 22554517; lyf971@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators did a pilot study to compare 5 patients using Cook double-catheter balloon priming and 5 patients using Propess. The investigators found the mean priming to delivery interval was 1971.6 minutes in Propess group and 1212.0 minutes in Cook double-catheter balloon group. The investigators assumed ratio of sample size in Propess and Cook double-catheter balloon was 1:1. In order to achieve 35% reduction of priming to delivery interval, a sample size of 28 is required for Type I error of 0.05, and Type II error of 0.2.

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)