Comparison Between Propess and Cook Double-balloon Catheter for Cervical Priming: a Randomized Controlled Trial

Delivery Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438081
• Other study ID #: UW 24-172
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: Yin Fong Leung, MBBS
• Phone: 852 22554517
• Email: lyf971[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

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

Related Conditions & MeSH terms

• Delivery Problem
• Dystocia

Intervention

Combination Product:
• Cook 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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Priming to delivery interval	Time for priming (device placement) to delivery interval	1 year
Secondary	Vaginal delivery within 24 hours after priming	delivery within 24 hours	1 year
Secondary	Caesarean section rate	need of resort to Caesarean section and the corresponding indication	1 year
Secondary	Vaginal delivery rate	included instrumental delivery, e.g. vacuum extraction, forcep delivery	1 year
Secondary	Priming to induction interval	Time from priming to induction	1 year
Secondary	Need of induction with oxytocin	Chance of going into spontaneous labor after priming	1 year
Secondary	Amount of oxytocin use	calculate the amount of oxytocin use	1 year
Secondary	Malpresentation after priming	to confirm if cephalic presentation before start of induction	1 year
Secondary	Failed induction rate	defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin	1 year
Secondary	Uterine hyperstimulation	defined by a single contraction lasting for more than 2 minutes or more than 5 contractions in 10 minutes for 30 minutes	1 year
Secondary	Suspected intrauterine infection rate	infection rate that require antibiotics treatment	1 year
Secondary	Primary postpartum haemorrhage	Blood loss >500ml within 24 hours of delivery	1 year
Secondary	Length of hospital stay	calculate length of hospital stay after delivery	1 year
Secondary	Maternal satisfaction with the procedure	on a visual analogue scale of 0-10, 10 is most satisfactory	1 year