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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dinoprostone vaginal insert | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone | Drug | The DVI contains 10 mg Dinoprostone |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of women with cervical ripening success | Defined as either Bishop Score (BS) ≥7 or a vaginal delivery | Within 12 hours of vaginal insert administration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of nulliparous and multiparous subjects with cervical ripening success | Collected labour data and delivery data | Within 12 hours of Investigational Medicinal Product (IMP) administration |
| Proportion of subjects delivering vaginally |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Medical Center and Research Institute for Maternal and Child Health | Izumi | Osaka | Japan | |||
| Hamamatsu University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33094550 | Result | Itoh H, Ishii K, Shigeta N, Itakura A, Hamada H, Nagamatsu T, Ishida T, Bungyoku Y, Falahati A, Tomisaka M, Kitamura M. Efficacy and safety of controlled-release dinoprostone vaginal delivery system (PROPESS) in Japanese pregnant women requiring cervical ripening: Results from a multicenter, randomized, double-blind, placebo-controlled phase III study. J Obstet Gynaecol Res. 2021 Jan;47(1):216-225. doi: 10.1111/jog.14472. Epub 2020 Oct 22. |
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| Placebo | Drug | The placebo product is identical with the active product except that it does not contain Dinoprostone. |
|
Collected labour and delivery data
| Within 12 hours of IMP administration |
| Proportion of subjects delivering vaginally | Collected labour data and delivery data | Within the first admission to hospital |
| Proportion of subjects with a BS increase ≥3 points from baseline | Measured by BS assessments | Within 12 hours of IMP administration |
| Proportion of subjects who have a caesarean delivery within the first admission to hospital | Data collected during the first admission to hospital | At time of delivery |
| Proportion of subjects who receive pre-delivery oxytocic drugs and dose of pre-delivery oxytocic drugs | Collected pre-delivery data | From the IMP removal to delivery |
| Proportion of subjects who undergo mechanical cervical ripening | Collected labour data | At least 60 minutes after the removal of the IMP |
| Duration of mechanical cervical ripening for subjects who undergo mechanical Cervical ripening | Measured as start date and time of first mechanical ripening and the end date and time of last mechanical ripening | Time from at least 60 minutes after the removal of the IMP until end of any mechanical ripening |
| Proportion of subjects with BS ≥7 | Among those having onset of labour while IMP is in-situ | At onset of labour |
| Time from IMP administration to onset of active labour | Within the first admission to hospital | Interval from IMP administration to onset of active labour |
| Time from IMP administration to vaginal delivery, caesarean delivery and any delivery | Within the first admission to hospital | Interval from IMP administration to delivery |
| Type, frequency and intensity of intrapartum adverse events (AEs), postpartum AEs and neonatal AEs | Assessed up to time when the subjects are discharged from the hospital | From obtaining the informed consent through end of trial (expected average of up to 1 week) |
| Type, frequency and intensity of intrapartum AEs | Assessed up to time when the deliveries occur | From onset of labour to the removal of the IMP |
| Change in maternal parameters of vital signs (blood pressure, heart rate and body temperature) | Assessed up to time when the subjects are discharged from the hospital | From baseline through end of trial (expected average of up to 1 week) |
| Change in maternal parameters of haematology, clinical chemistry and urinalysis | Assessed up to time when the subjects are discharged from the hospital | From baseline to end of trial (expected average of up to 1 week) |
| Proportion of neonates with Apgar Score <7 | Measured as Apgar Score assessments | 5 minutes post-birth |
| pH in umbilical artery blood samples | pH evaluation | At birth |
| Rate of admission to neonatal intensive care unit (NICU) for at least 24 hours | Admission/discharge data from NICU | After delivery |
| Hamamatsu |
| Shizuoka |
| Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | Japan |
| Itabashi Chuo Medical Center | tabashi City | Tokyo | Japan |
| Asahi General Hospital | Chiba | Japan |
| University of Tsukuba Hospital | Ibaraki | Japan |
| Hori Hospital | Kanagawa | Japan |
| Aizenbashi Hospital | Osaka | Japan |
| Osaka University Hospital | Osaka | Japan |
| Rinku General Medical Center | Osaka | Japan |
| Juntendo University Hospital | Tokyo | Japan |
| Keio University Hospital | Tokyo | Japan |
| Seibo Hospital | Tokyo | Japan |
| Showa University Hospital | Tokyo | Japan |
| St.Luke's International Hospital | Tokyo | Japan |
| The University of Tokyo Hospital | Tokyo | Japan |
| Tokyo Metropolitan Bokutoh Hospital | Tokyo | Japan |
| Tokyo Metropolitan Tama Medical Center | Tokyo | Japan |
| Keiyu Hospital | Yokohama | Japan |
| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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