Cervical Ripening
Conditions
Brief 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.
Interventions
DRUGDinoprostone
The DVI contains 10 mg dinoprostone
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of women with cervical ripening success | Within 12 hours of vaginal insert administration | Defined as either Bishop Score (BS) ≥7 or a vaginal delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who undergo mechanical cervical ripening | At least 60 minutes after the removal of the IMP | Collected labour data |
| Proportion of nulliparous and multiparous subjects with cervical ripening success | Within 12 hours of Investigational Medicinal Product (IMP) administration | Collected labour data and delivery data |
| Proportion of subjects delivering vaginally | Within 12 hours of IMP administration | Collected labour data and delivery data |
| Proportion of subjects with a BS increase ≥3 points from baseline | Within 12 hours of IMP administration | Measured by BS assessments |
| Proportion of subjects who have a caesarean delivery within the first admission to hospital | At time of delivery | Data collected during 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 | Measured as start date and time of first mechanical ripening and the end date and time of last mechanical ripening |
| Proportion of subjects with BS ≥7 | At onset of labour | Among those having onset of labour while IMP is in-situ |
| Time from IMP administration to onset of active labour | Interval from IMP administration to onset of active labour | Within the first admission to hospital |
| Proportion of subjects who receive pre-delivery oxytocic drugs and dose of pre-delivery oxytocic drugs | From the IMP removal to delivery | Collected pre-delivery data |
| 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) | Assessed up to time when the subjects are discharged from the hospital |
| Type, frequency and intensity of intrapartum AEs | From obtaining the informed consent to the removal of the IMP | Assessed up to time when the deliveries occur |
| 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) | Assessed up to time when the subjects are discharged from the hospital |
| Change in maternal parameters of haematology, clinical chemistry and urinalysis | From baseline to end of trial (expected average of up to 1 week) | Assessed up to time when the subjects are discharged from the hospital |
| Proportion of neonates with Apgar Score <7 | 5 minutes post-birth | Measured as Apgar Score assessments |
| pH in umbilical artery blood samples | At birth | pH evaluation |
| Rate of admission to neonatal intensive care unit (NICU) for at least 24 hours | After delivery | Admission/discharge data from NICU |
| Time from IMP administration to vaginal delivery, caesarean delivery and any delivery | Interval from IMP administration to delivery | Within the first admission to hospital |
Countries
Japan
Outcome results
None listed