NCT02225353

Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

A Randomized, Open-Label, Controlled, Multi-Center Study on the Efficacy of a Sustained Release Progesterone Cerclage Cervical Pessary at Doses of 6.3 g or 7.7 g for the Prevention of Preterm Birth and a Maximum Duration of 20 Weeks.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.

Detailed description

Participant selection will be performed by screening the general population of pregnant women with single fetus monitored by the Hospital Healthcare Network, to investigate by serial transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women with a single fetus and cervical length ≥10 mm presenting one or more of the following risk factors: 1. preterm birth prior to 35 (34 weeks and 6 days) weeks of gestation; 2. premature rupture of membranes prior to 35 (34 and 6 days) weeks of gestation. After insertion of the pessary or beginning of the administration with vaginal progesterone capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be monitored every 4 weeks at the most or more often, if the site has established so as a control standard. After 28 weeks, patients should be monitored every 2 weeks. The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be compared between the control group and the 2 groups with the pessaries containing different doses of progesterone.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DRUG	Progesterone Cervical Pessary 6.3 g	Progesterone Cervical Pessary low dose
DRUG	Progesterone 200 mg vaginal capsules	Progesterone 200 mg vaginal capsules daily
DRUG	Progesterone Cervical Pessary 7.7 g	Progesterone Cervical Pessary high dose

Timeline

• Start date: 2013-09-02
• Primary completion: 2017-03-13
• Completion: 2017-03-13
• First posted: 2014-08-26
• Last updated: 2018-10-23
• Results posted: 2018-10-23

Locations

4 sites across 1 country: Chile