Progesterone and Cervical Pessary in Twins (NCT03058536) | Clinical Trial Compass
UnknownPhase 2/3
Progesterone and Cervical Pessary in Twins
Brazil312 participantsStarted 2017-02-21
Plain-language summary
The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.
Who can participate
Age range16 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* Twin pregnancy ( dichorionic or monochorionic diamniotic)
* Both fetuses alive
* Asymptomatic short cervix according to gestational age ( measurement less or equal 30 mm between 16 weeks + 0 day and 22 weeks + 0 day, less or equal 25 mm between 22 weeks + 1 day and 24 weeks + 0 day and less or equal 20 mm between 24 weeks + 1 day and 27 weeks + 6 days)
* Gestational age between 16 to 27weeks and 6 days
* Intact membranes
* Informed consent
Exclusion Criteria:
* Monoamniotic twins
* Twin Twin transfusion syndrome
* Rupture membranes
* Major malformation or chromosomal abnormality at least one fetus
* Women with Cervical cerclage in the current pregnancy
* Ballooning of membranes outside the cervix into the vagina
* Placenta previa
* Treatment with progesterone before randomization
* Allergy of the excipientes of the micronized progesterone
* Labor
* Severe hepatic disfunction, porphyria, otosclerosis, severe depression
* Use of drugs that interfere the effects of progesterone