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

NCT03067597 | Completed Phase 3

• 1 other identifier: 000261
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Cervical Ripening

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (18)

• Proportion of nulliparous and multiparous subjects with cervical ripening success

  Within 12 hours of Investigational Medicinal Product (IMP) administration

• Proportion of subjects delivering vaginally

  Within 12 hours of IMP administration

• Proportion of subjects delivering vaginally

  Within the first admission to hospital

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

  Within 12 hours of IMP administration

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

  At time of delivery

Study Arms (1)

Dinoprostone vaginal insert (DVI)

EXPERIMENTAL

Drug: Dinoprostone

Interventions

Dinoprostone DRUG

The DVI contains 10 mg dinoprostone

Also known as: CERVIDIL®, PROPESS®

Dinoprostone vaginal insert (DVI)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (14)

Yokota Maternity Hospital

Maebashi, Gunma, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Location

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi, Osaka, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Location

Itabashi Chuo Medical Center

tabashi City, Tokyo, Japan

Location

University of Tsukuba Hospital

Ibaraki, Tsukuba, Japan

Location

Hori Hospital

Kanagawa, Japan

Location

Rinku General Medical Center

Osaka, Japan

Location

Juntendo University Hospital

Tokyo, Japan

Location

Keio University Hospital

Tokyo, Japan

Location

The University of Tokyo Hospital

Tokyo, Japan

Location

Tokyo Metropolitan Bokutoh Hospital

Tokyo, Japan

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: March 1, 2017
• Study Start: February 22, 2017
• Primary Completion: February 24, 2018
• Study Completion: February 24, 2018
• Last Updated: April 9, 2021

Record last verified: 2018-03

Locations

JP (14)