Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Naturally conceived diamniotic twin pregnancies.

• Absence of major fetal abnormalities (such as neural tube defects, abdominal wall defects, cardiac defects, hydrocephalus, malformations that course with polyhydramnios) at the anomaly scan.

• Gestational age between 18 - 21+6weeks at the moment of randomization.

• Patients that are not allergic to the progesterone capsule excipients (arachis oil, soy and lecithin).

• Patients who do not use other medicines that can alter the progesterone effects, such as: barbituric, carbamazepine, hydantoin, rifampicin, betablockers, teofiline or ciclosporin.

• Porphyria, otoscleroses, malignant disease or severe depressive state.

Exclusion Criteria:

• Premature rupture of membranes diagnosed at the moment of recruitment.

• Subsequent diagnosis of major fetal abnormalities.

• Twin to twin transfusion syndrome diagnosed during the course of the pregnancy.

• Presence of ovular infection.

• Death of one or both fetuses in any time of the pregnancy.

• Giving up or discontinuing the use of the medication.

• Elective or iatrogenic premature birth (before 34 weeks).

• Present or past history of thromboembolic disease

• Uterine malformation

• Known or suspected breast or genitals malignancy tumor

• Plan to move to another city during pregnancy

• Placenta Previa