An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

• Status: Completed
• Trial end date: 2018-02-24
• Target enrollment: 0
• Participant gender: Female

Summary

To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

• Pregnant women at term (≥37 weeks 0 day and < 41 weeks 0 day 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 active 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 (≤ mean 1.5 SD of 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 V2

• Ruptured membranes ≥ 48 hours prior to IMP administration

• 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 (e.g., 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 investigators would impair participation in the trial