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Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
Not Recruiting
Trial ID: NCT00946088
Purpose
Preterm delivery is the most common cause of infant morbidity and mortality in the United
States. Some women have episodes of preterm labor during their pregnancy which can be
temporarily stopped. These women, however, are at high risk for delivering before term. At
this time, we do not have sufficient evidence to use any medication to help prevent these
women from delivering early. Recently, preliminary studies have shown that progesterone may
help prevent some women at high risk for preterm delivery from delivering early. Our study
will investigate whether progesterone can help this specific group of women, women with
arrested preterm labor, deliver healthy infants at term.
Official Title
Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
Stanford Investigator(s)
Yasser El-Sayed, Professor
Charles B. and Ann L. Johnson Professor in the School of Medicine and Professor, by courtesy, of Pediatrics (Neonatology) and of Surgery
Maurice L. Druzin
Professor of Obstetrics and Gynecology (Maternal Fetal Medicine) and, by courtesy, of Pediatrics
Eligibility
Inclusion Criteria:1. Pregnant women with arrested preterm labor between 24+0 to 33+6 weeks
pregnant.
2. Intact membranes 3. Singleton pregnancy 4. Greater than or equal to 18 years of age 5.
Cervical dilation less than or equal to 4cm Exclusion Criteria:1. Any contraindication to
on-going pregnancy 2. Placental abruption 3. Placenta previa 4. Lethal fetal anomalies 5.
Premature rupture of membranes 6. Multiple gestation 7. Less than 18 years old 8. Known
allergy to any component of the study medication or placebo 9. Severe maternal medical
illness
Intervention(s):
drug: Polyethylene glycol&hydrogenated vegetable oil.
drug: Progesterone
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elizabeth S Langen, MD