A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
- Registration Number
- NCT03067727
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 114
- Pregnant women at term (≥ 41 weeks 0 day and ≤ 41 weeks 6 days 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
- Women in 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 (≤ 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Dinoprostone vaginal insert Dinoprostone -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Proportion of subjects delivering vaginally Within the first admission to hospital Collected labour data and delivery 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 a BS increase ≥3 points from baseline Within 12 hours of IMP administration Measured by BS assessments
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
Type, frequency and intensity of intrapartum AEs From onset of labour to the removal of the IMP Assessed up to time when the deliveries occur
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
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
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 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
Rate of admission to neonatal intensive care unit (NICU) for at least 24 hours After delivery Admission/discharge data from NICU
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
Trial Locations
- Locations (20)
Seirei Hamamatsu General Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Itabashi Chuo Medical Center
🇯🇵Itabashi, Tokyo, Japan
University of Tsukuba Hospital
🇯🇵Ibaraki, Japan
Hori Hospital
🇯🇵Kanagawa, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Tokyo, Japan
Keiyu Hospital
🇯🇵Yokohama, Japan
Aizenbashi Hospital
🇯🇵Osaka, Japan
Tokyo Metropolitan Tama Medical Center
🇯🇵Tokyo, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
🇯🇵Izumi, Osaka, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Asahi General Hospital
🇯🇵Chiba, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Rinku General Medical Center
🇯🇵Osaka, Japan
Juntendo 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