ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00579553
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:

This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.


Condition or disease Intervention/treatment Phase
Infant, Premature Premature Birth Drug: Intramuscular Progesterone Drug: Vaginal Progesterone Not Applicable

Detailed Description:

This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.
Study Start Date : October 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
Intramuscular Progesterone
Drug: Intramuscular Progesterone
Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P
Other Name: 17 alpha hydroxyprogesterone caproate
Experimental: B
Vaginal Progesterone
Drug: Vaginal Progesterone
Vaginal Progesterone: 100 mg vaginal suppository daily



Primary Outcome Measures :
  1. To assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth. [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton pregnancies
  • History of spontaneous preterm brith (between 20 weeks and 36 weeks 6 days)
  • Gestational age between 16 weeks 0 days and 20 weeks 6 days.
  • Signed consent to participate in the trial

Exclusion Criteria:

  • Multiple Gestation
  • Prior elective fetal reduction or planned termination
  • Known spontaneous reduction to singleton
  • Major fetal anomaly or known fetal chromosomal abnormalities
  • Progesteone used this pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579553


Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Andrew Elimian, MD University of Oklahoma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00579553     History of Changes
Other Study ID Numbers: Progesterone75,643
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by University of Oklahoma:
Pre Term
Pre Term Birth
Premature Birth
Premature baby
High risk pregnancy
Progesterone
IM Progesterone
Vaginal Progesterone

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists