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Comparing IM vs. Vaginal Progesterone for Pre-term Birth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00579553
First received: December 18, 2007
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention
Infant, Premature
Premature Birth
Drug: Intramuscular Progesterone
Drug: Vaginal Progesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Intramuscular Versus Vaginal Progesterone for Prevention of Preterm Birth.

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: October 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Vaginal Progesterone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00579553     History of Changes
Other Study ID Numbers: Progesterone75,643
Study First Received: December 18, 2007
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

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 Complications
Obstetric Labor, Premature
Pregnancy Complications
11-hydroxyprogesterone
17-alpha-hydroxy-progesterone caproate
Progesterone
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on November 25, 2014