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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02225353 |
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Date of registration:
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04/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
PCP002 |
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Scientific title:
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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. |
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Date of first enrolment:
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September 2, 2013 |
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Target sample size:
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271 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02225353 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Grünenthal Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Grünenthal GmbH |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preterm Birth
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Intervention(s)
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Drug: Progesterone 200 mg vaginal capsules
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Drug: Progesterone Cervical Pessary 6.3 g
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Drug: Progesterone Cervical Pessary 7.7 g
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Primary Outcome(s)
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Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation
[Time Frame: Up to 36 weeks of gestational age]
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Secondary Outcome(s)
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Acceptability and Tolerance of Use of the Cerclage Pessary
[Time Frame: Up to 36 weeks of gestational age]
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Number of Adverse Events Related With the Use of Treatment
[Time Frame: Up to 36 weeks of gestational age]
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Anatomical Feature: Length of the Uterine Cervix
[Time Frame: Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.]
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Anatomical Feature: Position of the Uterine Cervix
[Time Frame: Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.]
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Number of Participants With Premature Rupture of Membranes
[Time Frame: Up to 36 weeks of gestational age]
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Secondary ID(s)
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EC12012/10IEI-9339
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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