Labour induction in women at term with unfavourable cervix

ISRCTN	ISRCTN70322889
DOI	https://doi.org/10.1186/ISRCTN70322889
Protocol serial number	N/A
Sponsor	Istanbul Bakirkoy Women and Children Hospital (Turkey)
Funder	Istanbul Bakirkoy Women and Children Hospital (Turkey) - Department of Obstetrics and Gynecology

Submission date: 16/08/2009
Registration date: 18/09/2009
Last edited: 18/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gokhan Yildirim
Scientific

Atakent Mah. Soyak Olypiakent Sitesi D10-57
K. Cekmece
Istanbul
34303
Türkiye

Email	gokhan73yildirim@gmail.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Can we use concurrent oxytocin infusion with dinoprostone vaginal pessary for cervical ripening and labour induction?
Ethics approval(s)	Istanbul Bakirkoy Women and Children Hospitals Local Ethics Board approved on the 7th November 2008 (ref: 162)
Health condition(s) or problem(s) studied	Labour induction
Intervention	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 fornix. This sustained-released product releases dinoprostone at a low but steady rate (0.3 mg/h). It remained in the vagina for up to 12 hours, as recommended by the manufacturer. At the same time, oxytocin infusion at 4 milliunits/min was started for all participants. Oxytocin infusion was doubled every 30 minutes to a maximum of 40 milliunits/min or until four contractions in 10 minutes was achieved. Women who were assigned randomly to receive the sustained-released dinoprostone followed six hours later by high-dose oxytocin (Group B) had a single dose placed high into the vaginal fornix. A standart high-dose of intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 4 mU/min was increased at 30 minute intervals by 4 mU/min to a maximum dose 40 mU/min or until four contractions in 10 minutes was achieved.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	Oxytocin, dinoprostone
Primary outcome measure(s)	Number (rate) of women who went to vaginally deliver within 24 hours of the initiation of the protocol.
Key secondary outcome measure(s)	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.
Completion date	01/02/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	500
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	01/02/2009

Locations

Countries of recruitment

Türkiye

Study participating centre

Atakent Mah. Soyak Olypiakent Sitesi D10-57

Istanbul
34303
Türkiye

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes