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

Ferring

Status and phase

Completed

Phase 3

Conditions

Cervical Ripening

Treatments

Drug: Dinoprostone

Study type

Interventional

Funder types

Industry

Identifiers

NCT03067597

000261

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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