Prevention of preterm birth in twin pregnancies - Randomised trial of progesterone versus placebo”

Phase 1

Conditions: Spontaneous preterm birth in twin pregnancies.
MedDRA version: 20.1Level: LLTClassification code 10023555Term: Labour prematureSystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2015-005180-16-IT

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

Inclusion Criteria

• 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

Exclusion Criteria

• 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 twinto-
twin transfusion syndrome (TTTS) (20% discordance in
crown-rump length [CRL]);
• 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
• Porphyria
• Cerebral haemorrhage
• Allergy to sunflower oil, soy lethicin, gelatin, glycerol (E422),
titanium dioxide (E171)