NCT02329535

Trial name or title	Comparing double dose of vaginal progesterone to no treatment for prevention of preterm birth in twins and short cervix
Methods	Open‐label, parallel, randomised trial
Participants	Estimated enrolment: 214 Inclusion criteria: twin gestation, certain dating (documented first trimester ultrasound, or a reliable menstrual date confirmed by an ultrasound performed before 20 weeks of gestation), age > 18 years, gestational age 16 ‐ 26, cervical length < 25 mm, intact membranes, informed consent Exclusion criteria: major malformation or chromosomal abnormality to at least 1 fetus, higher order pregnancy, mocochorional‐monoamniotic twin, death of 1 fetus, cervical dilatation > 3 cm, chronic medical conditions that would interfere with study participation or evaluation of the treatment (e.g. seizures, psychiatric disorders, uncontrolled chronic hypertension, congestive heart failure, chronic renal failure, uncontrolled diabetes mellitus with end‐organ dysfunction, active thrombophlebitis or a thromboembolic disorder, history of hormone‐associated thrombophlebitis or thromboembolic disorders, active liver dysfunction or disease, known or suspected malignancy of the breast or genital organs)
Interventions	Intervention: treatment with 400 mg micronised progesterone (Utrogestan) daily up to 36 weeks of gestation Control: no treatment. Regular follow‐up
Outcomes	Preterm delivery (time frame: up to 25 weeks from randomisation) Rate of preterm delivery before 37 weeks
Starting date	January 2015
Contact information	Noah Zafran noah_za@clalit.org.il
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