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A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03067727
Collaborator
(none)
114
Enrollment
20
Locations
2
Arms
16.9
Actual Duration (Months)
5.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (41 Weeks of Gestation) Requiring Cervical Ripening
Actual Study Start Date :
Apr 3, 2017
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Aug 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dinoprostone vaginal insert

Drug: Dinoprostone
The DVI contains 10 mg Dinoprostone
Other Names:
  • CERVIDIL®
  • PROPESS®

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    The placebo product is identical with the active product except that it does not contain Dinoprostone.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Proportion of subjects delivering vaginally [Within 12 hours of IMP administration]

      Collected labour and delivery data

    3. Proportion of subjects delivering vaginally [Within the first admission to hospital]

      Collected labour data and delivery data

    4. Proportion of subjects with a BS increase ≥3 points from baseline [Within 12 hours of IMP administration]

      Measured by BS assessments

    5. 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

    6. 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

    7. Proportion of subjects who undergo mechanical cervical ripening [At least 60 minutes after the removal of the IMP]

      Collected labour data

    8. 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

    9. Proportion of subjects with BS ≥7 [At onset of labour]

      Among those having onset of labour while IMP is in-situ

    10. Time from IMP administration to onset of active labour [Interval from IMP administration to onset of active labour]

      Within the first admission to hospital

    11. Time from IMP administration to vaginal delivery, caesarean delivery and any delivery [Interval from IMP administration to delivery]

      Within the first admission to hospital

    12. 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

    13. 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

    14. 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

    15. 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

    16. Proportion of neonates with Apgar Score <7 [5 minutes post-birth]

      Measured as Apgar Score assessments

    17. pH in umbilical artery blood samples [At birth]

      pH evaluation

    18. Rate of admission to neonatal intensive care unit (NICU) for at least 24 hours [After delivery]

      Admission/discharge data from NICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Osaka Medical Center and Research Institute for Maternal and Child Health Izumi Osaka Japan
    2 Hamamatsu University Hospital Hamamatsu Shizuoka Japan
    3 Seirei Hamamatsu General Hospital Hamamatsu Shizuoka Japan
    4 Jichi Medical University Hospital Shimotsuke Tochigi Japan
    5 Itabashi Chuo Medical Center Itabashi Tokyo Japan
    6 Asahi General Hospital Chiba Japan
    7 University of Tsukuba Hospital Ibaraki Japan
    8 Hori Hospital Kanagawa Japan
    9 Aizenbashi Hospital Osaka Japan
    10 Osaka University Hospital Osaka Japan
    11 Rinku General Medical Center Osaka Japan
    12 Juntendo University Hospital Tokyo Japan
    13 Keio University Hospital Tokyo Japan
    14 Seibo Hospital Tokyo Japan
    15 Showa University Hospital Tokyo Japan
    16 St.Luke's International Hospital Tokyo Japan
    17 The University of Tokyo Hospital Tokyo Japan
    18 Tokyo Metropolitan Bokutoh Hospital Tokyo Japan
    19 Tokyo Metropolitan Tama Medical Center Tokyo Japan
    20 Keiyu Hospital Yokohama Japan

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Clinical Development Support, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03067727
    Other Study ID Numbers:
    • 000262
    First Posted:
    Mar 1, 2017
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Sep 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Dinoprostone

    Study Results

    No Results Posted as of Nov 3, 2020