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-BG
• Lead Sponsor: Fundación para la Formación e Investigación Sanitaria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1188

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 1188
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 or nuchal translucency thickness >3.5 mm identified at the 11-13 weeks’ scan;
• MCDA twin pregnancies in which there are early signs of twin-totwin
transfusion syndrome (TTTS), defined as 20% discordance in
crown-rump length (CRL) at the 11-13 weeks scan;
• Women who are unconscious or severely ill, those with learning
difficulties, or serious mental illness;
• Hypersensitivity to progesterone;
• Women taking progesterone at any time within the previous 7 days;
• Participation in another drug trial 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified