SOLVE: A trial randomising patients between a medical device (called Dilapan-S) and the standard pessary drug (Propess) to compare them in the process of cervical ripening before induction of labour
- Conditions
- ChildbirthPregnancy and Childbirth
- Registration Number
- ISRCTN20131893
- Lead Sponsor
- Birmingham Women’s and Children’s NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 674
Current inclusion criteria as of 05/11/2020:
1. Women >16 years of age
2. Able to provide informed consent
3. Singleton pregnancy
4. Indication for IoL
5. Pregnancy =37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan)
6. Living fetus with vertex presentation
7. Intact membranes
Previous inclusion criteria:
1. Women aged 16 years and over
2. Understanding and capable to provide informed consent
3. Singleton pregnancy
4. Indication for IoL
5. Pregnancy =37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan at 11-14 weeks)
6. Living fetus with vertex presentation
7. Intact membranes
8. Bishop Score =6 points
Current exclusion criteria as of 05/11/2020:
1. Women already receiving oxytocin
2. Diagnosis of fulminant preeclampsia/eclampsia
3. Contraindication to Dinoprostone or Dilapan
4. If Dinoprostone for loL is non-compliant with local policy
5. Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour
Previous exclusion criteria:
1. Contraindication for vaginal delivery (i.e., placenta previa)
2. When labour has already started (defined as regular painful contractions)
3. When oxytocin is being administered
4. Fulminant preeclampsia/eclampsia
5. Clinical signs of uterine, cervical, vaginal or vulval infection (except Group B Streptococcal colonisation)
6. Known allergy or contraindication to drug or device ingredients
7. Previous uterine body/midline/classical caesarean section (EXCEPT lower segment caesarean section)
8. More than one previous caesarean section
9. Known uterine abnormality
10. Suspected fetal hypoxia (i.e., CTG recording evaluated as abnormal prior to pre-induction initiation)
11. Unstable lie
12. Active antepartum haemorrhage at the time of induction
13. Four or more full-term deliveries
14. Known fetal anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measure as of 05/11/2020:<br> Efficacy of the synthetic osmotic cervical dilator in cervical ripening, prior to Induction of Labour (IoL), in comparison to dinoprostone vaginal insert to successfully achieve vaginal delivery as recorded on the Baseline and Birth Case Report Form (CRF) for the trial.<br><br> Previous primary outcome measure:<br> Efficacy of the synthetic osmotic cervical dilator in cervical ripening, prior to Induction of Labour (IoL), in comparison to dinoprostone vaginal insert to successfully achieve vaginal delivery within 36 hours as recorded on the Baseline and Birth Case Report Form (CRF) for the trial.<br>
- Secondary Outcome Measures
Name Time Method