Condition category
Pregnancy and Childbirth
Date applied
24/04/2018
Date assigned
29/05/2018
Last edited
25/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Induction of labour is one of the most common procedures in obstetrics and about 1 in 4 women will go through the process. Generally, induction of labour methods can be divided into: mechanical (intracervical catheter, laminaria, synthetic osmotic cervical dilators, extra-amniotic saline infusion) and pharmacological (the use of drugs, like prostaglandins and oxytocin).
The aim of this study is to assess patients' overall satisfaction with Cook Cervical Ripening Balloon using two different protocols (outpatient and inpatient) and to determine the difference between them, if any, by using a questionnaire.

Who can participate?
Pregnant women aged 18 to 40 years who have never given birth before

What does the study involve?
Patients are divided into two groups. Both groups receive Cook Cervical Ripening Balloon for the induction of labour. They are exposed to the product for the same period of time (12 hours). The only difference between two groups is where patients are during the period of induction (those in the inpatient group remain in the hospital whilst those in the outpatient group go home).

What are the possible benefits and risks of participating?
Participants may benefit from induction of labour, as Cook Cervical Ripening Balloon is an effective and proven tool.
Risks in the induction of labour are well known but so far, publications have shown CRB has reduced risk compared with prostagladins (most usual method for induction of labour) as stated in the official leaflet of CRB.
Where is the study run from?
National Maternity Hospital (Ireland)

When is the study starting and how long is it expected to run for?
September 2017 to June 2018

Who is funding the study?
National Maternity Hospital (Ireland)

Who is the main contact?
Dr Branko Denona (Public)

Trial website

Contact information

Type

Public

Primary contact

Dr Branko Denona

ORCID ID

http://orcid.org/0000-0002-4410-9900

Contact details

National Maternity Hospital
Dublin
D2
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pilot comparative study on patient satisfaction with Cervical Ripening Balloon using inpatient and outpatient protocol

Acronym

Study hypothesis

To assess patients’ satisfaction on induction of labour with Cook’s Cervical Ripening Balloon using two different protocols, inpatient and outpatient. Satisfaction of each protocol is assessed by patients' completed questionnaire.

Ethics approval

National Maternity Hospital Dublin Ethics Committee, 29/03/2018, ref: EC 04.2018

Study design

Prospective comparative pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Obstetrics: induction of labour

Intervention

40 patients who fulfill criteria and are willing to participate in the study are equally divided into two different groups. In both groups Cook Cervical Ripening Balloon (CRB) is inserted in the cervix of the uterus and is removed after 12 hours as per instructions of the manufacturer. CRB can be removed before expiration of 12 hours if there is a clinical indication.
Patients in the first group (inpatient protocol) remain in the hospital after CRB is placed. Other group of patients (outpatient protocol) leave the hospital after placement of the CRB and return when the CRB is due to be removed. CRB is used for the same period of time in both groups.
After removal of the CRB, patients in both groups are examined and continue induction of labour as per hospital protocol.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Patient satisfaction with Cook Cervical Ripening Balloon is measured using Patient Experience Questionnaire post induction process

Secondary outcome measures

1. Efficiency of Cook’s CRB for induction of labour is assessed by possibility to perform artificial rupture of membranes post removal of CRB
2. Delivery within 24 hours of receiving induction of labor method is recorded.
3. Cesarean delivery rate is recorded at delivery.
4. Instrumental delivery rate is recorded at delivery.
5. Additional use of prostaglandin (1 or 2 doses) is recorded after reassessment following removal of CRB
6. Additional use of oxytocin for labour induction or augmentation is recorded after reassessment following removal of CRB
7. Maternal infection defined as maternal temperature greater than 38⁰C, endometritis, chorioamnionitis or antibiotic usage is recorded following placement of CRB
8. Neonatal adverse events (if any) are recorded throughout.

Overall trial start date

01/09/2017

Overall trial end date

30/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Nulliparous women with singleton pregnancies
2. Aged 18 to 40 years
3. The fetus is in cephalic presentation
4. Low risk pregnancies going for induction of labour for postdates pregnancies as per protocol in National Maternity Hospital

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Any pre-existing medical condition or medical condition of pregnancy
2. Pathological CTG prior to induction
3. Oligohydramnios or any other abnormal findings on post-dates scan
4. Maternal age <18 years old or >40 years old

Recruitment start date

01/05/2018

Recruitment end date

28/06/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

National Maternity Hospital
Holles Street
Dublin
D2
Ireland

Sponsor information

Organisation

National Maternity Hospital

Sponsor details

Holles Street
Dublin
D2
Ireland

Sponsor type

Hospital/treatment centre

Website

http://www.nmh.ie/

Funders

Funder type

Hospital/treatment centre

Funder name

National Maternity Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study is planned to be published in peer reviewed journal.

IPD sharing statement:
Data will not be available as the this is only a pilot study and would most likely be followed by a larger, cohort study. For this reason collected data will only be saved for the time of the study and once completed will be erased and hold no value for the future studies except for the final results which will be published.

Intention to publish date

01/09/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes