Premature Birth Clinical Trial
NCT number | NCT00120640 |
Other study ID # | HIC#27253 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | July 11, 2005 |
Last updated | September 18, 2012 |
Start date | July 2005 |
Verified date | September 2012 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emerging as the standard of care for prevention of preterm delivery in asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our goal is to evaluate whether or not progesterone is also effective in reducing preterm birth in symptomatic patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients in preterm labor as described above. - Patients with an accurately dated singleton gestation. Accurate dating is defined as estimated date of delivery (EDD) based on last menstrual period (LMP) dating (280 days after the first day of the LMP) confirmed by an ultrasound done before 20 weeks, which yields an EDD within 10 days of LMP dating. If the LMP is not available, the EDD must be based on 2 ultrasounds performed at least 2 weeks apart, which are concordant within 5 days of the same EDD. - Patients with their first presentation of preterm labor will be invited to participate. - Patients whose plan of management includes admission to the hospital and administration of antenatal steroids for fetal well being. Exclusion Criteria: - Rupture of membranes - Major known fetal anomalies - Cervical dilation > 4 centimeters - Uterine anomalies - Cervical cerclage - Treatment during this pregnancy with progesterone after 14 weeks' gestation (use up to 14 weeks' gestation is permitted) - Previous admission for preterm labor - Contraindications to tocolysis, including fetal distress, chorioamnionitis, preeclampsia, hemodynamic instability - Coexisting maternal disease including hypertension requiring medical therapy, cancer, seizure disorder, thromboembolic disorders, liver disease. Patients treated with oral beta adrenergics for asthma are also excluded. - Age < 18 years |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Yale University |
da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. — View Citation
McLean M, Bisits A, Davies J, Woods R, Lowry P, Smith R. A placental clock controlling the length of human pregnancy. Nat Med. 1995 May;1(5):460-3. — View Citation
Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. Erratum in: N Engl J Med. 2003 Sep 25;349(13):1299. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delivery <37 weeks' gestation | |||
Primary | Delivery <34 weeks' gestation | |||
Primary | Delivery <32 weeks' gestation | |||
Secondary | Neonatal outcomes |
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