A randomised controlled trial of a Synthetic Osmotic cervical dilator for induction of Labour in comparison to dinoprostone Vaginal insErt:the SOLVE trial

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10046790Term: Uterine hypertonusSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: LLTClassification code 10018162Term: Genital oedema femaleSystem Organ Class: 100000004872; Induction of Labour; MedDRA version: 20.0Level: PTClassification code 10000154Term: Abnormal labour affecting foetusSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: LLTClassification code 10028816Term: Nausea and vomitingSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: LLTClassification code 10016492Term: Fetal distress syndromeSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: PTClassification code 10046820Term: Uterine ruptureSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 20.0Level: LLTClassification code 10054386Term: Fetal heart rate disorderSystem Organ Class: 100000004849; MedDRA version: 20.0Level: PTClassification code 10013442Term: Disseminated intravascular coagulationSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: PTClassification code 10002198Term: Anaphylactic reactionSystem Organ Class: 10021428 - Immune system disorders

• Registration Number: EUCTR2016-004726-42-GB
• Lead Sponsor: Birmingham Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-15
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 860

Inclusion Criteria

Women must meet the following criteria prior to initiation of IoL:
1.= 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 at 11-14 weeks)
6.Living fetus with vertex presentation
7.Intact membranes
8.Bishop Score (NICE Modified version July 2008) < 6 points

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Women already receiving oxytocin
2.Diagnosis of fulminant preeclampsia / eclampsia
3.Contraindication to PROPESS or DILAPAN
4.If PROPESS for IoL 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of the synthetic osmotic cervical dilator in cervical ripening, for IoL, in comparison to dinoprostone vaginal insert to successfully achieve vaginal delivery within 36 hours from randomisation.;Secondary Objective: To determine the response to a synthetic osmotic cervical dilator in cervical ripening, for IoL, in comparison to dinoprostone vaginal insert on maternal and neonatal outcomes. ;Primary end point(s): Failure to achieve vaginal delivery within 36 hours from randomisation ;Timepoint(s) of evaluation of this end point: 36 hours after administration of Propess or Dilapan-S