Comparing 3-hourly with 6-hourly dinoprostone vaginal tablet for labour induction in nulliparous women with an unfavourable cervix at term

Comparing 3-hourly with 6-hourly dinoprostone vaginal tablet for labour induction in nulliparous women with an unfavourable cervix at term: A randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94131405

Enrollment

238

Registered

2013-04-23

Start date

2013-02-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Labour induction in nullliparous women with an unfavourable cervix at term Pregnancy and Childbirth

Interventions

Regimen 1 a) Dinoprostone (3 mg) vaginal tablet, followed 3 hours later by b) Dinoprostone (3 mg) vaginal tablet if still indicated, followed 3 hours later by c) Dinoprostone ( 3mg) vaginal tablet

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Scheduled for induction of labour 2. Nulliparous (no previous delivery > 20 weeks) 3. Term gestation (= 37 weeks) 4. Bishop score on recruitment = 6 5. Intact membranes 6. Singleton pregnancy 7. Cephalic presentation 8. Reassuring cardiotocogram

Exclusion criteria

Exclusion criteria: 1. Previous uterine incision or injury (e.g. myomectomy, perforation) 2. Known severe fetal anomaly 3. No significant contractions (< 1 in 10 minutes) 4. Allergy to dinoprostone

Design outcomes

Primary

Measure	Time frame
1. Vaginal delivery in 24 hours 2. Maternal satisfaction with the birth process using a 10 point numerical rating scale	—

Secondary

Measure	Time frame
1. Mode of delivery (and indications for operative delivery) 2. Neonatal outcome (admission, umbilical cord blood pH, Apgar score) 3. Analgesia use in during induction and labour 4. Cardiotocogram abnormalities in first 12 hours of labour induction (including tachysystole, hypertonus, hyperstimulation) 5. Meconium stained liquor 6. Blood loss during labour and delivery 7. Maternal fever (any maternal temperature = 380 C during labour or before discharge) 8. Maternal pain score at 6 hours of labour induction (if undelivered) 9. Induction to delivery interval 10. Induction to hospital discharge interval	—

Measure

Time frame

1. Mode of delivery (and indications for operative delivery) 2. Neonatal outcome (admission, umbilical cord blood pH, Apgar score) 3. Analgesia use in during induction and labour 4. Cardiotocogram abnormalities in first 12 hours of labour induction (including tachysystole, hypertonus, hyperstimulation) 5. Meconium stained liquor 6. Blood loss during labour and delivery 7. Maternal fever (any maternal temperature = 380 C during labour or before discharge) 8. Maternal pain score at 6 hours of labour induction (if undelivered) 9. Induction to delivery interval 10. Induction to hospital discharge interval

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Countries

Malaysia

Outcome results

None listed

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