Labour induction in women at term with unfavourable cervix
| ISRCTN | ISRCTN70322889 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70322889 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Atakent Mah. Soyak Olypiakent Sitesi D10-57
K. Cekmece
Istanbul
34303
Türkiye
| gokhan73yildirim@gmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Oxytocin, dinoprostone |
| Primary outcome measure | 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 study start date | 01/10/2007 |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
34303
Türkiye
Sponsor information
Istanbul Bakirkoy Women and Children Hospital (Turkey)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynecology
Istanbul
34720
Türkiye
| Phone | +90 (9)212 543 6270 |
|---|---|
| istanbulea4@saglik.gov.tr |
Funders
Funder type
Hospital/treatment centre
Istanbul Bakirkoy Women and Children Hospital (Turkey) - Department of Obstetrics and Gynecology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
