The PREDICT Study: The PREterm Delivery In Twins StudyEffectiveness of vaginally administered progesterone to prevent preterm delivery in twin pregnancies – A multicentre randomized trial - PREDICT

Conditions: Prevention of preterm labour

Registration Number: EUCTR2006-000503-41-AT

Lead Sponsor: Rigshospitalet, Ultrasound Clinic 4023

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 750

Inclusion Criteria

1) Twin pregnancy
2) Informed consent
3) 18-23 weeks’ gestation
4) Participants must be able to speak and understand the language spoken in the respective centres

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Age < 18 years
2) Known allergy to progesterone or peanuts
3) Active thromboembolic disorders or a history of hormone-associated thromboembolic disorders
4) Rupture of membranes at the time of inclusion
5) Monoamniotic twins
6) Pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion
7) Multiple pregnancies reduced to twin pregnancies
8) Known significant structural or chromosomal fetal abnormality
9) Chorionicity not assessed before 15 weeks
10) Known or suspected malignancy in genitals or breasts
11) Known liver disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness of progesterone in the prevention of preterm delivery in twin pregnancies;Secondary Objective: 1) Physical and neurological development of the children at 6 and 18 months<br>2) The relationship between cervical length and prophylactic progesterone treatment<br>3) Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA<br>4) Assessment of the potential anti-inflammatory effect of progesterone by cytokine-measurements<br>5) Assessment of the effect of progesterone on CRH-levels in twin pregnancies<br>;Primary end point(s): The primary end point is the incidence of delivery < 34 weeks, in the study group versus the control group.

Secondary Outcome Measures