NCT03067727CompletedPhase 3
A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (41 Weeks of Gestation) Requiring Cervical Ripening
Ferring Pharmaceuticals20 sites in 1 country114 target enrollmentStarted: April 3, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 114
- Locations
- 20
- Primary Endpoint
- The proportion of women with cervical ripening success
Study Overview
Brief Summary
To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women at term (≥ 41 weeks 0 day and ≤ 41 weeks 6 days of gestation) at the Baseline visit
- •Candidate for pharmacologic induction of labour
- •Singleton pregnancy with live infant in vertex presentation
- •Baseline BS ≤ 4 at the Baseline visit
- •Parity ≤ 3 (parity is defined as one or more births live or stillbirths after 22 weeks 0 day gestation)
- •Written informed consent
Exclusion Criteria
- •Women in labour
- •Presence of uterine or cervical scar including scar from previous caesarean section, and previous cone biopsy of the cervix and loop electrosurgical excision procedure (LEEP)
- •Uterine abnormality e.g. bicornuate uterus
- •Administration of oxytocin, any cervical ripening or labour inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to IMP administration. Magnesium sulfate is permitted if prescribed as treatment for preeclampsia or pregnancy induced hypertension
- •Presence of the following conditions/symptoms:
- •Systolic blood pressure > 160 mmHg or diastolic blood pressure > 110 mmHg. Platelets < 100,000/µL. Increased liver function tests (2x upper limits of normal range). Severe, persistent right upper quadrant/epigastric pain. Progressive renal insufficiency: Creatinine > 1.1 mg/dL, Doubling of creatinine in the absence of other renal disease. Pulmonary edema. New onset cerebral or visual disturbances
- •Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation
- •Diagnosed congenital abnormalities, not including polydactyly
- •Suspected or confirmed intrauterine growth retardation (≤ 1.5 SD of mean normal estimated fetal weight for dates)
- •Any evidence of fetal compromise at baseline visit (e.g., non-reassuring fetal heart rate pattern, meconium staining, history of non-reassuring fetal status or abnormal umbilical artery Doppler wave form)
- •Intake of medication with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) at baseline visit
- •Ruptured membranes
- •Suspected clinical chorioamnionitis
- •Current pelvic inflammatory disease, unless adequate prior treatment has been instituted
- •Fever (axillary temperature ≥ 38.0 °C) at the Baseline visit
- •Any condition in which vaginal delivery is contraindicated (eg., placenta previa or any unexplained vaginal bleeding at any time after 24 weeks 0 day during this pregnancy)
- •Known or suspected allergy to, dinoprostone other prostaglandins or any constituent of IMP
- •Any condition urgently requiring delivery
- •History of asthma or glaucoma
- •Unable to comply with the protocol
- •Any other medical condition which in the judgement of the investigator would impair participation in the trial
Arms & Interventions
Dinoprostone vaginal insert
Experimental
Intervention: Dinoprostone (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The proportion of women with cervical ripening success
Time Frame: Within 12 hours of vaginal insert administration
Defined as either Bishop Score (BS) ≥7 or a vaginal delivery
Secondary Outcomes
- Proportion of subjects delivering vaginally(Within the first admission to hospital)
- Duration of mechanical cervical ripening for subjects who undergo mechanical Cervical ripening(Time from at least 60 minutes after the removal of the IMP until end of any mechanical ripening)
- Proportion of subjects who undergo mechanical cervical ripening(At least 60 minutes after the removal of the IMP)
- Proportion of subjects with a BS increase ≥3 points from baseline(Within 12 hours of IMP administration)
- Proportion of subjects who receive pre-delivery oxytocic drugs and dose of pre-delivery oxytocic drugs(From the IMP removal to delivery)
- Type, frequency and intensity of intrapartum AEs(From onset of labour to the removal of the IMP)
- Proportion of subjects who have a caesarean delivery within the first admission to hospital(At time of delivery)
- Change in maternal parameters of haematology, clinical chemistry and urinalysis(From baseline to end of trial (expected average of up to 1 week))
- Proportion of neonates with Apgar Score <7(5 minutes post-birth)
- pH in umbilical artery blood samples(At birth)
- Proportion of nulliparous and multiparous subjects with cervical ripening success(Within 12 hours of Investigational Medicinal Product (IMP) administration)
- Proportion of subjects with BS ≥7(At onset of labour)
- Time from IMP administration to onset of active labour(Interval from IMP administration to onset of active labour)
- Time from IMP administration to vaginal delivery, caesarean delivery and any delivery(Interval from IMP administration to delivery)
- Type, frequency and intensity of intrapartum adverse events (AEs), postpartum AEs and neonatal AEs(From obtaining the informed consent through end of trial (expected average of up to 1 week))
- Rate of admission to neonatal intensive care unit (NICU) for at least 24 hours(After delivery)
- Change in maternal parameters of vital signs (blood pressure, heart rate and body temperature)(From baseline through end of trial (expected average of up to 1 week))
Investigators
Study Sites (20)
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