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

• Status: Completed
• Trial end date: 2017-03-13
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Grünenthal GmbH; Laboratorios Andromaco S.A.
• Collaborator: Laboratorios Andromaco S.A.
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Women with a single pregnancy and a cervical length of 10 mm - 25 mm between 16 and 24 weeks of gestation, without any previous factors.

• Women with a single pregnancy with 10 mm or more cervical length between 16 and 24 weeks of gestation, and pre-existing risk factors risk factors for preterm birth:

• Previous preterm birth before week 35.

• Previous rupture of membranes before week 35

Exclusion Criteria:

• Pregnancies with:

• Major fetal abnormalities, such as lethal malformations or malformations requiring pre- or post-natal surgery; and fetal death before inclusion into the study.

• History of rupture of membranes or prophylactic cerclage before study entry.

• Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).

• Unconscious, severely ill or mentally disabled patients, or under 16 years of age.

• Patients for whom use of progesterone is contraindicated.

• Patients with history of thrombosis.