NCT00120640

Brief Summary

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

First QC Date

July 11, 2005

Last Update Submit

September 18, 2012

Conditions

Premature BirthPremature Labor

Keywords

Premature birthPremature laborProgesterone

Outcome Measures

Primary Outcomes (3)

  • Delivery <37 weeks' gestation

  • Delivery <34 weeks' gestation

  • Delivery <32 weeks' gestation

Secondary Outcomes (1)

  • Neonatal outcomes

Interventions

17 hydroxyprogesterone caproate intramuscular injectionsDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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. doi: 10.1056/NEJMoa035140.

    PMID: 12802023BACKGROUND

  • 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. doi: 10.1067/mob.2003.41.

    PMID: 12592250BACKGROUND

  • 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. doi: 10.1038/nm0595-460.

    PMID: 7585095BACKGROUND

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Anna K Sfakianaki, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Edmund F Funai, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 18, 2005

Study Start

July 1, 2005

Last Updated

September 19, 2012

Record last verified: 2012-09