A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
NCT ID: NCT03067727
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
114 participants
INTERVENTIONAL
2017-04-03
2018-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dinoprostone vaginal insert
Dinoprostone
The DVI contains 10 mg Dinoprostone
Placebo
Placebo
The placebo product is identical with the active product except that it does not contain Dinoprostone.
Interventions
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Dinoprostone
The DVI contains 10 mg Dinoprostone
Placebo
The placebo product is identical with the active product except that it does not contain Dinoprostone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 (≤ 1.5 SD of mean 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 baseline visit
* Ruptured membranes
* 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 (eg., 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 investigator would impair participation in the trial
20 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan
Hamamatsu University Hospital
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
Countries
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References
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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.
Other Identifiers
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000262
Identifier Type: -
Identifier Source: org_study_id