NCT00457886

Brief Summary

The purpose of this study is to measure hormones in the blood known to affect the timing of delivery after a single injection of 17-P in order to help understand its mechanism of action in preventing preterm delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

First QC Date

April 6, 2007

Last Update Submit

March 7, 2017

Conditions

Preterm Delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Spontaneous preterm delivery in a previous pregnancy, are between 15-20 weeks gestation during the current pregnancy, and have already decided whether or not to receive 17-alphahydroxyprogesterone caproate (17-P) for the prevention of preterm delivery.

You may not qualify if:

  • Multiple gestation
  • Known fetal anomaly
  • Progesterone or heparin treatment during the current pregnancy
  • Seizure disorder
  • Pre-existing or gestational diabetes
  • Hypertension requiring medication
  • Thyroid or adrenal gland disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • John Queenan, MD

    Georgetown University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2007

First Posted

April 9, 2007

Study Start

July 1, 2005

Study Completion

June 1, 2007

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

US(1)