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

Cervical Ripening Clinical Trial

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

Clinical 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03067597
Study type Interventional
Source Ferring Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date February 22, 2017
Completion date February 24, 2018
View Details
See also
  Status Clinical Trial Phase
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Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT00374621 - Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate N/A
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Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
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Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Recruiting NCT01156948 - Misoprostol For Nulliparous Women Before Hysteroscopy Phase 3
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2