Labour induction in women at term with unfavourable cervix

Sustained-release dinoprostone vaginal pessary with concurrent high-dose oxytocin infusion compared sustained-release dinoprostone vaginal pessary followed six hours later by high dose oxytocin infusion for labour induction in women at term with unfavourable cervix: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70322889

Enrollment

500

Registered

2009-09-18

Start date

2007-10-01

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 Pregnancy and Childbirth Abnormalities of forces of labour

Interventions

Women who were assigned randomly to receive the sustained-released dinoprostone (Propess®, Vitalis, Turkey) with concurrent high-dose oxytocin (Group A) had a single dose placed high into the vaginal

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Single live fetus in cephalic presentation 2. Gestational age greater than or equal to 37 weeks as determined by the last menstrual period or by a first- or second-trimester ultrasound scan 3. Bishop score less than or equal to 4 4. Females aged 20 - 40 years

Exclusion criteria

Exclusion criteria: 1. Any contraindication to vaginal delivery 2. Previous caesarean section 3. Multiple pregnancy 4. Estimated fetal weight greater than 4500 g 5. Breech presentation 6. Antepartum haemorrhage 7. Evidence of fetal distress

Design outcomes

Primary

Measure	Time frame
Number (rate) of women who went to vaginally deliver within 24 hours of the initiation of the protocol.	—

Secondary

Measure	Time frame
1. Incidence of excess uterine activity (uterine hyperstimulation or uterine tachysystole) 2. Labour induction-to-delivery interval 3. Labour induction-to-active phase interval (defined as at least 6 uterine contractions per 20-minute intervals, with at least 70% effaced cervix and a cervical dilatation of greater than or equal to 4) 4. Total number of doses of dinoprostone pessary used 5. Meconium-stained liquor 6. Mode of delivery 7. Instrumental delivery rate 8. Maternal satisfaction score for the birth process obtained within 24 hours of delivery (a visual analog scale (VAS) with a range of 0 to 10, with higher score denoting greater satisfaction, was used to gauge maternal satisfaction) 9. Visual analogue scale pain score (ranged from 0 to 10, with 0 representing no pain to 10 representing unbearable pain) 10. Rates of maternal and neonatal complications: 10.1. Maternal complications included: 10.1.1. Incidence of maternal side effects (nausea, vomiting, diarrhoea, pyrexia) 10.1.2. Postpartum haemorrhage (blood loss greater than 500) 10.1.3. Third- or fourth-degree lacerations 10.1.4. Intrapartum chorioamnionitis (defined as temperature greater than or equal to 38°C accompanied by maternal or fetal tachycardia [greater than 160 beats/min], uterine tenderness, malodorous amniotic fluid discharge, and/or maternal leukocytosis [white blood cell count greater than 15,000 cell/min^3]) 10.1.5. Postpartum endometritis (defined as temperature greater than or equal to 38°C accompanied by uterine tenderness and/or purulent or foul-smelling lochiae beyond the first 24 hours after delivery) 10.2. Neonatal complications noted were: 10.2.1. Apgar scores of less than 7 at 5 minutes 10.2.2. Neonatal jaundice 10.2.3. Rate of admission to the neonatal intensive care unit Seondary analysis based on parity was also planned.	—

Measure

Time frame

1. Incidence of excess uterine activity (uterine hyperstimulation or uterine tachysystole) 2. Labour induction-to-delivery interval 3. Labour induction-to-active phase interval (defined as at least 6 uterine contractions per 20-minute intervals, with at least 70% effaced cervix and a cervical dilatation of greater than or equal to 4) 4. Total number of doses of dinoprostone pessary used 5. Meconium-stained liquor 6. Mode of delivery 7. Instrumental delivery rate 8. Maternal satisfaction score for the birth process obtained within 24 hours of delivery (a visual analog scale (VAS) with a range of 0 to 10, with higher score denoting greater satisfaction, was used to gauge maternal satisfaction) 9. Visual analogue scale pain score (ranged from 0 to 10, with 0 representing no pain to 10 representing unbearable pain) 10. Rates of maternal and neonatal complications: 10.1. Maternal complications included: 10.1.1. Incidence of maternal side effects (nausea, vomiting, diarrhoea, pyrexia) 10.1.2. Postpartum haemorrhage (blood loss greater than 500) 10.1.3. Third- or fourth-degree lacerations 10.1.4. Intrapartum chorioamnionitis (defined as temperature greater than or equal to 38°C accompanied by maternal or fetal tachycardia [greater than 160 beats/min], uterine tenderness, malodorous amniotic fluid discharge, and/or maternal leukocytosis [white blood cell count greater than 15,000 cell/min^3]) 10.1.5. Postpartum endometritis (defined as temperature greater than or equal to 38°C accompanied by uterine tenderness and/or purulent or foul-smelling lochiae beyond the first 24 hours after delivery) 10.2. Neonatal complications noted were: 10.2.1. Apgar scores of less than 7 at 5 minutes 10.2.2. Neonatal jaundice 10.2.3. Rate of admission to the neonatal intensive care unit Seondary analysis based on parity was also planned.

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Countries

Turkey

Outcome results

None listed

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