Status:
COMPLETED
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Lead Sponsor:
Grünenthal GmbH
Collaborating Sponsors:
Laboratorios Andromaco S.A.
Conditions:
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 (...
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 ultr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT02225353
Start Date
September 2 2013
End Date
March 13 2017
Last Update
October 23 2018
Active Locations (4)
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1
Universidad de Chile, Hospital Barros Luco
Santiago, Chile, 7501257
2
Complejo Asistencial Dr. Sótero del Río (CASR)
Santiago, Chile
3
Unidad de Alto Riesgo Obstétrico y Medicina Perinatal y en el Centro Perinatal Oriente (CERPO), Hospital Santiago Oriente, Dr. Luis Tisné Brousse
Santiago, Chile
4
Universidad de Chile, Hospital Clínico San Borja Arriarán
Santiago, Chile