Condition category
Pregnancy and Childbirth
Date applied
16/08/2009
Date assigned
18/09/2009
Last edited
18/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Hospital’s 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

Publication citations

Additional files

Editorial Notes