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Balloon Catheter Versus Propess for Labour Induction (PROBIT-F)

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ClinicalTrials.gov Identifier: NCT03199820
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
City, University of London
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:
This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.

Condition or disease Intervention/treatment Phase
Childbirth Problems Labor Complication Device: Cook cervical balloon Drug: Prostin E2 Vaginal Suppository Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomised controlled trial of feasibility
Masking: Single (Outcomes Assessor)
Masking Description: The trial statistician will be blinded to group allocation.
Primary Purpose: Health Services Research
Official Title: Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : January 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cook Cervical balloon
Cook cervical double balloon catheter
Device: Cook cervical balloon
trans-cervical balloon catheter for out-patient labour induction

Active Comparator: Prostin E2 Vaginal suppository
Prostaglandin E2 sustained release vaginal insert
Drug: Prostin E2 Vaginal Suppository
Propess Vaginal suppository for out-patient Labour induction
Other Name: Propess




Primary Outcome Measures :
  1. feasibility of randomised Induction of Labour Trial in Out-patient setting [ Time Frame: 12 months ]
    Number of eligible women willing to enrol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Pregnant women with a single fetus and uncomplicated pregnancy, with a gestational age > 37+ 0 weeks, needing induction of labour

  1. ≥18 years of age
  2. No medical risk factors.

Exclusion Criteria:

  1. Out-patient induction of labour is deemed unsuitable for the following women on the grounds of safety -

    • Grand multiparous women (Parity 5 or more)
    • Multiple pregnancy
    • Women with complex medical or obstetric problems (i.e. placenta previa, recurrent antepartum hemorrhage, diabetes, pre-eclampsia, Intrauterine growth restriction (UGR), Obstetric Cholestasis)
    • Previous caesarean section/uterine scar
  2. Women who are contracting and/ or requiring analgesia
  3. Women who do not fully understand the information leaflet and unable to provide full informed consent
  4. Women for whom out-patient induction is unsuitable according to local hospital protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199820


Locations
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United Kingdom
Medway Maritime Hospital
Gillingham, Kent, United Kingdom, ME7 5NY
St Georges University Hospital NHS Foundation Trust
Tooting, London, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's, University of London
City, University of London
Investigators
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Principal Investigator: Amarnath Bhide, MD St. George's University Hospitals Foundation Trust

Publications of Results:

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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03199820     History of Changes
Other Study ID Numbers: 13.0029
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs