An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dinoprostone vaginal insert (DVI)
|
Drug: Dinoprostone
The DVI contains 10 mg dinoprostone
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 delivering vaginally [Within the first admission to hospital]
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
- 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
- Proportion of subjects who undergo mechanical cervical ripening [At least 60 minutes after the removal of the IMP]
Collected labour data
- 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
- Time from IMP administration to vaginal delivery, caesarean delivery and any delivery [Interval from IMP administration to delivery]
Within the first admission to hospital
- 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
Eligibility Criteria
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)
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yokota Maternity Hospital | Maebashi | Gunma | Japan | |
| 2 | Kitasato University Hospital | Sagamihara | Kanagawa | Japan | |
| 3 | Osaka Medical Center and Research Institute for Maternal and Child Health | Izumi | Osaka | Japan | |
| 4 | Hamamatsu University Hospital | Hamamatsu | Shizuoka | Japan | |
| 5 | Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | Japan | |
| 6 | Jichi Medical University Hospital | Shimotsuke | Tochigi | Japan | |
| 7 | Itabashi Chuo Medical Center | Itabashi | Tokyo | Japan | |
| 8 | University of Tsukuba Hospital | Ibaraki | Tsukuba | Japan | |
| 9 | Hori Hospital | Kanagawa | Japan | ||
| 10 | Rinku General Medical Center | Osaka | Japan | ||
| 11 | Juntendo University Hospital | Tokyo | Japan | ||
| 12 | Keio University Hospital | Tokyo | Japan | ||
| 13 | The University of Tokyo Hospital | Tokyo | Japan | ||
| 14 | Tokyo Metropolitan Bokutoh Hospital | Tokyo | Japan |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 000261