Contact information
Type
Scientific
Primary contact
Dr Gokhan Yildirim
ORCID ID
Contact details
Atakent Mah. Soyak Olypiakent Sitesi D10-57
K. Cekmece
Istanbul
34303
Turkey
gokhan73yildirim@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
Can we use concurrent oxytocin infusion with dinoprostone vaginal pessary for cervical ripening and labour induction?
Ethics approval
Istanbul Bakirkoy Women and Children Hospitals Local Ethics Board approved on the 7th November 2008 (ref: 162)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Oxytocin, dinoprostone
Primary outcome measures
Number (rate) of women who went to vaginally deliver within 24 hours of the initiation of the protocol.
Secondary outcome measures
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.
Overall trial start date
01/10/2007
Overall trial end date
01/02/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
500
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
01/02/2009
Locations
Countries of recruitment
Turkey
Trial participating centre
Atakent Mah. Soyak Olypiakent Sitesi D10-57
Istanbul
34303
Turkey
Sponsor information
Organisation
Istanbul Bakirkoy Women and Children Hospital (Turkey)
Sponsor details
Department of Obstetrics and Gynecology
Istanbul
34720
Turkey
+90 (9)212 543 6270
istanbulea4@saglik.gov.tr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Istanbul Bakirkoy Women and Children Hospital (Turkey) - Department of Obstetrics and Gynecology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary