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Cervical RipeningPhase 3NCT03067597

An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term

A Phase 3 study testing Dinoprostone in people with Cervical Ripening, run by Ferring Pharmaceuticals at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Cervical Ripening
What is being tested?
Dinoprostone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
14 sitesJapan
Study dates
22 Feb 2017to 24 Feb 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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)
  • 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
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka

  • University of Tsukuba Hospital

    Ibaraki, Tsukuba

  • Osaka Medical Center and Research Institute for Maternal and Child Health

    Izumi, Osaka

  • Hori Hospital

    Kanagawa

  • Yokota Maternity Hospital

    Maebashi, Gunma

  • Rinku General Medical Center

    Osaka

  • Kitasato University Hospital

    Sagamihara, Kanagawa

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi

  • Itabashi Chuo Medical Center

    tabashi City, Tokyo

  • Juntendo University Hospital

    Tokyo

  • Keio University Hospital

    Tokyo

  • The University of Tokyo Hospital

    Tokyo

  • Tokyo Metropolitan Bokutoh Hospital

    Tokyo

Other trials in Japan

About this study

Official title: A Multicentre, Open-label Phase III Trial Investigating the Efficacy and Safety of FE 999901 Vaginal Insert in Pregnant Women at Term (≥37 Weeks and <41 Weeks of Gestation) Requiring Cervical Ripening

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.

Being tested
Dinoprostone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DinoprostoneDrug

    Also called CERVIDIL®, PROPESS®

    The DVI contains 10 mg dinoprostone

Study groups in NCT03067597
Study groupRoleWhat they receive
Dinoprostone vaginal insert (DVI)ExperimentalNot described
Receives: Drug: Dinoprostone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of women with cervical ripening success

    Defined as either Bishop Score (BS) ≥7 or a vaginal delivery

    Measured: Within 12 hours of vaginal insert administration

Secondary outcomes (18)

  1. Proportion of nulliparous and multiparous subjects with cervical ripening success

    Collected labour data and delivery data

    Measured: Within 12 hours of Investigational Medicinal Product (IMP) administration

  2. Proportion of subjects delivering vaginally

    Collected labour data and delivery data

    Measured: Within 12 hours of IMP administration

  3. Proportion of subjects delivering vaginally

    Collected labour data and delivery data

    Measured: Within the first admission to hospital

  4. Proportion of subjects with a BS increase ≥3 points from baseline

    Measured by BS assessments

    Measured: Within 12 hours of IMP administration

  5. Proportion of subjects who have a caesarean delivery within the first admission to hospital

    Data collected during the first admission to hospital

    Measured: At time of delivery

  6. Proportion of subjects who receive pre-delivery oxytocic drugs and dose of pre-delivery oxytocic drugs

    Collected pre-delivery data

    Measured: From the IMP removal to delivery

  7. Proportion of subjects who undergo mechanical cervical ripening

    Collected labour data

    Measured: At least 60 minutes after the removal of the IMP

  8. 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

    Measured: Time from at least 60 minutes after the removal of the IMP until end of any mechanical ripening

  9. Proportion of subjects with BS ≥7

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

    Measured: At onset of labour

  10. Time from IMP administration to onset of active labour

    Within the first admission to hospital

    Measured: Interval from IMP administration to onset of active labour

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

    Within the first admission to hospital

    Measured: Interval from IMP administration to delivery

  12. 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

    Measured: From obtaining the informed consent through end of trial (expected average of up to 1 week)

  13. Type, frequency and intensity of intrapartum AEs

    Assessed up to time when the deliveries occur

    Measured: From obtaining the informed consent to the removal of the IMP

  14. 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

    Measured: From baseline through end of trial (expected average of up to 1 week)

  15. Change in maternal parameters of haematology, clinical chemistry and urinalysis

    Assessed up to time when the subjects are discharged from the hospital

    Measured: From baseline to end of trial (expected average of up to 1 week)

  16. Proportion of neonates with Apgar Score <7

    Measured as Apgar Score assessments

    Measured: 5 minutes post-birth

  17. pH in umbilical artery blood samples

    pH evaluation

    Measured: At birth

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

    Admission/discharge data from NICU

    Measured: After delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2017
  2. Study start22 Feb 2017
  3. Primary completion24 Feb 2018
  4. Study completion24 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03067597
Sponsor's protocol ID
000261
Status last verified
Mar 2018
First submitted
9 Feb 2017
Last updated
9 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dinoprostone in people with Cervical Ripening, run by Ferring Pharmaceuticals at 14 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of women with cervical ripening success (time frame: Within 12 hours of vaginal insert administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03067597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.

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