Preterm Delivery Clinical Trial
Official title:
Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.
Status | Completed |
Enrollment | 677 |
Est. completion date | September 2010 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Twin pregnancy - Informed consent - 18-23 weeks' gestation - Participants must be fluent in the language spoken in the respective centres Exclusion Criteria: - Age < 18 years - Known allergy to progesterone or peanuts - Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders - Rupture of membranes at the time of inclusion - Monoamniotic twins - Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion - Multiple pregnancies reduced to twin pregnancies - Known significant structural or chromosomal fetal abnormality - Chorionicity not assessed before 15 weeks - Known or suspected malignancy in genitals or breasts - Known liver disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Austria | Graz University Hospital | Graz | |
Austria | Innsbruck University Hospital | Innsbruck | |
Austria | Klagenfurt Hospital | Klagenfurt | |
Austria | Vienna University Hospital | Vienna | |
Denmark | Aalborg Hospital | Aalborg | |
Denmark | Skejby Hospital | Aarhus | |
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Glostrup Hospital | Glostrup | |
Denmark | Gentofte Hospital | Hellerup | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Hilleroed Hospital | Hilleroed | |
Denmark | Holbaek Hospital | Holbaek | |
Denmark | Hvidovre Hospital | Hvidovre | |
Denmark | Odense University Hospital | Odense | |
Denmark | Roskilde Hospital | Roskilde | |
Denmark | Soenderborg Hospital | Soenderborg | |
Denmark | Viborg Hospital | Viborg |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | AP Moeller Foundation, The Danish Medical Research Council, The Danish Medical Society in Copenhagen |
Austria, Denmark,
Klein K, Rode L, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Vaginal micronized progesterone and risk of preterm delivery in high-risk twin pregnancies: secondary analysis of a placebo-controlled randomized trial and meta-analysis. Ultraso — View Citation
Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obst — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of delivery < 34 weeks, in the study group versus the control group | Participants will be followed until 3 weeks after delivery | No | |
Secondary | Physical and neurological development of the children at 6 and 18 months | 2 years after delivery | Yes | |
Secondary | The relationship between cervical length and prophylactic progesterone treatment | Participants will be followed until 3 weeks after delivery | No | |
Secondary | Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA | Participants will be followed until 3 weeks after delivery | No | |
Secondary | Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements | Participants will be followed until 3 weeks after delivery | No | |
Secondary | Assessment of the effect of progesterone on CRH-levels in twin pregnancies | Participants will be followed until 3 weeks after delivery | No |
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