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Induction of labour with balloon catheter or balloon catheter with controlled-release dinoprostone vaginal insert

Foley catheter vs Foley catheter and controlled-release dinoprostone insert labour induction in nulliparous women: a randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12282883
Enrollment
206
Registered
2018-12-03
Start date
2018-12-11
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Induction of labour in nulliparous women at term Pregnancy and Childbirth

Interventions

Randomisation will be completed using the Random.org random number generator in a random block of 4 or 8 by an investigator who is not involved in recruitment. The random allocation sequence will be p

Sponsors

Obstetric and gynecology department , UMMC
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous women (no previous pregnancy beyond 20 weeks of gestation) 2. Unfavourable cervix (Bishop score =5) 3. Aged 18 years or older 4. =37 weeks of gestation at enrolment 5. Singleton birth 6. Cephalic presentation 7. Membrane intact 8. Normal pre-induction CTG (cardiotocography) 9. Contraction not more than 2:10

Exclusion criteria

Exclusion criteria: 1. Gross fetal anomaly 2. Allergy to latex or dinoprostone

Design outcomes

Primary

MeasureTime frame
1. Interval between the start of induction and vaginal delivery as recorded in patient medical records 2. Maternal satisfaction with the birth experience from induction of labour to delivery assessed using a numerical rating scale. A Likert scale will be used to determine whether the patient would recommend the method they had for induction of labour to a friend who needs to undergo induction of labour. This assessment will be done as soon as practicable after delivery.

Secondary

MeasureTime frame
Maternal: 1. Pain at 6 hours after start of induction assessed using a pain score scale (numerical rating scale 0 to 10) 2. Mode of delivery. This information will be taken from patient medical records as soon as possible before patient discharge from hospital. 3. Amniotomy. This information will be taken from patient medical records as soon as possible before patient discharge from hospital. 4. Intrapartum Oxytocin (excluding third stage use). This information will be taken from patient medical records as soon as possible before patient discharge from hospital. 5. Delivery blood loss. This information will be taken from patient medical records as soon as possible before patient discharge from hospital. Neonatal: 6. Apgar score at 5 minutes after birth. This information will be taken from patient medical records as soon as possible before patient discharge from hospital. 7. Umbilical cord arterial pH at birth. This information will be taken from patient medical records as soon as possible before patient discharge from hospital. 8. Admission to neonatal intensive care unit at birth and reason for admission. This information will be taken from patient medical records as soon as possible before patient discharge from hospital.

Countries

Malaysia

Contacts

Public ContactNaumi Laboh

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026