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Comparison on patient satisfaction with Cervical Ripening Balloon using inpatient and outpatient protocol

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10109823
Enrollment
40
Registered
2018-05-29
Start date
2018-05-01
Completion date
Unknown
Last updated
2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetrics: induction of labour Pregnancy and Childbirth Labour

Interventions

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 cervi

Sponsors

National Maternity Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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 40 years old

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 38°C, endometritis, chorioamnionitis or antibiotic usage is recorded following placement of CRB 8. Neonatal adverse events (if any) are recorded throughout.

Countries

Ireland

Contacts

Public ContactBranko Denona

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026