Comparison on patient satisfaction with Cervical Ripening Balloon using inpatient and outpatient protocol
| ISRCTN | ISRCTN10109823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10109823 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/04/2018
- Registration date
- 29/05/2018
- Last edited
- 10/08/2020
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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 January 2020
Who is funding the study?
National Maternity Hospital (Ireland)
Who is the main contact?
Dr Branko Denona (Public)
Contact information
Public
National Maternity Hospital
Dublin
D2
Ireland
 ORCID ID |
0000-0002-4410-9900 |
|---|
Study information
| Study design | Prospective comparative pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pilot comparative study on patient satisfaction with Cervical Ripening Balloon using inpatient and outpatient protocol |
| Study objectives | 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(s) | National Maternity Hospital Dublin Ethics Committee, 29/03/2018, ref: EC 04.2018 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/09/2017 |
| Completion date | 31/01/2020 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 01/07/2020 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D2
Ireland
Sponsor information
Hospital/treatment centre
Holles Street
Dublin
D2
Ireland
| Website | http://www.nmh.ie/ |
|---|---|
"ROR" |
https://ror.org/03jcxa214 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study is planned to be published in peer reviewed journal. |
| IPD sharing plan | 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. |
Editorial Notes
10/08/2020: The trial was stopped due to participant recruitment issues.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
10/01/2020: The recruitment end date has been changed from 31/12/2019 to 01/07/2020.
19/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2019 to 31/12/2019.
2. The overall trial end date was changed from 01/07/2019 to 31/01/2020.
3. The intention to publish date was changed from 30/09/2019 to 01/06/2020.
14/01/2019: The following changes were made to the trial record:
1. The recruitment end date has been updated from 01/12/2018 to 01/07/2019.
2. The overall trial end date has been updated from 30/06/2018 to 01/07/2019.
3. The intention to publish date has been updated from 01/09/2019 to 30/09/2019.
06/08/2018: The recruitment end date was changed from 28/06/2018 to 01/12/2018.
