Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth (STTARS)

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Women pregnant with twins or triplets are at high risk of preterm birth, yet no intervention or approach has served to reduce this risk. A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units (MFMU) Network has, for the first time, demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery (i.e. progesterone therapy). Preterm birth was reduced by 35% among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo. The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The George Washington University Biostatistics Center
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate; Progesterone

Criteria

Inclusion Criteria:

• Twin or triplet pregnancy. Quadruplets reduced to triplets may be included, but no other prior reductions.

• Gestational age between 16 weeks 0 days to 20 weeks 6 days based on clinical information and evaluation of the first ultrasound.

• Signed patient authorization and consent form.

Exclusion Criteria:

• Prior elective fetal reduction in the current pregnancy, except in the case of a quadruplet gestation reduced to triplets.

• Planned fetal reduction or planned termination

• Monoamniotic gestation

• Twin-twin transfusion syndrome

• Fetal death or imminent fetal demise

• Major fetal anomaly (e.g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 12 weeks 0 days to 20 weeks 6 days by project estimated date of confinement (EDC) must be performed to rule out fetal anomalies

• Discordance in fetal size, defined as a discrepancy of 3 or more weeks in gestational age by ultrasound between the largest and the smallest fetus. Diagnosis is based on measurements made at the ultrasound done between 12 weeks 0 days and 20 weeks 6 days gestation

• Progesterone treatment used or planned after 14 weeks gestation

• Heparin therapy at a dose ≥ 10,000 units per day of unfractionated heparin, or any low molecular weight heparin during the current pregnancy, or thromboembolic disease for which such heparin treatment is planned (because of contraindication to intra-muscular injections)

• Current or planned cervical cerclage

• Uterine anomaly (uterine didelphys, bicornate uterus)

• Contraindication to intra-muscular injections

• Maternal medical conditions, such as: known idiopathic thrombocytopenia purpura (ITP) or a known platelet count less than 100,000 per cubic millimeter (because of contraindication to intra-muscular injections), hypertension requiring medication, diabetes managed with insulin or oral hypoglycemic agents

• Inability to arrange a pre-randomization ultrasound between 12 weeks 0 days and 20 weeks 6 days gestation

• Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality

• Prenatal follow-up or delivery planned elsewhere (unless the study visits can be made as scheduled and complete outcome information can be obtained)

• Participation in this trial in a previous pregnancy.