Early vaginal progesterone in the prevention of spontaneous preterm birth in twin pregnancy

Phase 1

• Conditions: Spontaneous preterm birth; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-005180-16-ES
• 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: 2016-05-17
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1180

Inclusion Criteria

Age > 18 years;
DCDA or MCDA twin pregnancies
Live fetuses at 11-13 weeks of gestation
English or Spanish (otherwise interpreters will be used
Informed and written consent
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Exclusion Criteria

Age < 18 years
Pregnancies complicated by major fetal abnormality identified at the 11- 13 weeks assessment, including nuchal translucency thickness >3.5 mm;
In MCDA twin pregnancies 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;
Concurrent participation in another drug trial or at any time within the previous 28 days;
Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.

Study & Design

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