## Protocol Section
### Identification Module
**NCT ID:** NCT06438081

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

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

#### Organization Study ID Info
**ID:** UW 24-172
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Hong Kong

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** True

**Is US Export:** True

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Delivery Problem

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** We did a pilot study to compare 5 patients using Cook double-catheter balloon priming and 5 patients using Propess. We found the mean priming to delivery interval was 1971.6 minutes in Propess group and 1212.0 minutes in Cook double-catheter balloon group. We 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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Combination Product: Cook double-balloon catheter

**Label:** Cook double-balloon catheter

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Combination Product: Cook double-balloon catheter

**Label:** Propess

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cook double-balloon catheter

- Propess

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

**Name:** Cook double-balloon catheter

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** Time for priming (device placement) to delivery interval

**Measure:** Priming to delivery interval

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** delivery within 24 hours

**Measure:** Vaginal delivery within 24 hours after priming

**Time Frame:** 1 year

**Description:** need of resort to Caesarean section and the corresponding indication

**Measure:** Caesarean section rate

**Time Frame:** 1 year

**Description:** included instrumental delivery, e.g. vacuum extraction, forcep delivery

**Measure:** Vaginal delivery rate

**Time Frame:** 1 year

**Description:** Time from priming to induction

**Measure:** Priming to induction interval

**Time Frame:** 1 year

**Description:** Chance of going into spontaneous labor after priming

**Measure:** Need of induction with oxytocin

**Time Frame:** 1 year

**Description:** calculate the amount of oxytocin use

**Measure:** Amount of oxytocin use

**Time Frame:** 1 year

**Description:** to confirm if cephalic presentation before start of induction

**Measure:** Malpresentation after priming

**Time Frame:** 1 year

**Description:** defined as cervix failed to dilate to more than 3cm after 12 hours use of oxytocin

**Measure:** Failed induction rate

**Time Frame:** 1 year

**Description:** defined by a single contraction lasting for more than 2 minutes or more than 5 contractions in 10 minutes for 30 minutes

**Measure:** Uterine hyperstimulation

**Time Frame:** 1 year

**Description:** infection rate that require antibiotics treatment

**Measure:** Suspected intrauterine infection rate

**Time Frame:** 1 year

**Description:** Blood loss \>500ml within 24 hours of delivery

**Measure:** Primary postpartum haemorrhage

**Time Frame:** 1 year

**Description:** calculate length of hospital stay after delivery

**Measure:** Length of hospital stay

**Time Frame:** 1 year

**Description:** on a visual analogue scale of 0-10, 10 is most satisfactory

**Measure:** Maternal satisfaction with the procedure

**Time Frame:** 1 year

### Eligibility Module

**Eligibility 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

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lyf971@hku.hk

**Name:** Yin Fong Leung, MBBS

**Phone:** 852 22554517

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Hong Kong

**Name:** Yin Fong Leung, MBBS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7594

- Name: Dystocia

- Relevance: HIGH

- As Found: Delivery Problem

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004420

- Term: Dystocia

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13041

- Name: Oxytocin

- Relevance: LOW

- As Found: Unknown

- ID: M17936

- Name: Dinoprostone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
