Prevention of preterm birth in twin pregnancies - Randomised trial of progesterone versus placebo”
- Conditions
- Spontaneous preterm birth in twin pregnancies.MedDRA version: 19.0Level: LLTClassification code 10023555Term: Labour prematureSystem Organ Class: 100000004868Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2015-005180-16-BE
- Lead Sponsor
- Fundación para la Formación e Investigación Sanitaria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 1180
• Age > 18 years;
• DCDA or MCDA twin pregnancies;
• Live fetuses at 11-13 weeks of gestation;
• Fluent in local language (otherwise interpreters will be used);
• Informed and written consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Pregnancies complicated by major fetal abnormality
identified at the 11-13 weeks assessment, including
nuchal translucency thickness >3.5 mm;
• MCDA twin pregnancies in which there are early signs of
twin-to-twin transfusion syndrome (TTTS) (20%
discordance in crown-rump length [CRL] and/or nuchal
translucency [NT]);
• Women who are unconscious or severely ill, those with
learning difficulties, or serious mental illness;
• Hypersensitivity to progesterone;
• Women taking progesterone regularly or at any time
within the previous 7 days;
• Concurrent participation in another drug trial or at any
time within the previous 28 days;
• Severe hepatic dysfunction [AST or ALT >3 times the
upper limit of normal (ULN) or bilirubin >2 x ULN],
mammary or genital tract carcinoma, thrombophlebitis or
thromboembolic disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method