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Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor

NCT01406197 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-26

No results posted yet for this study

Summary

This study will examine the effects of various formulations of progesterone on uterine electromyographic (EMG) activity in pregnant patients in premature labor to determine if progesterone will suppress uterine electrical activity and which formulation may be best for inhibition of uterine activity. Patients will be monitored prior to treatment and following treatment (every 2 to 4 hours) with one of three different formulations of progesterone for up to two days. Patients will continue to be observed until they deliver. Comparisons will be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24 and 48 hours and times of delivery after treatments (hours or days following treatments). Comparisons between mean values for EMG activity between the various treatments at the various times will also be made.

Conditions

  • Preterm Labor

Interventions

DRUG

Experimental: Vaginal progesterone

Vaginal progesterone formulation (150 mg micronized progesterone daily)

DRUG

Experimental: Topical progesterone

Progesterone will be applied daily (150 mg micronized progesterone)by topical application

DRUG

Experimental: Intramuscular progesterone

Preterm labor patients will be injected IM with micronized progesterone (50 mg/day).

Sponsors & Collaborators

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • James Balducci, MD · St. Joseph's Hospital and Medical Center, Phoenix

  • Robert Garfield, PhD · St. Joseph's Hospital and Medical Center, Phoenix

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406197 on ClinicalTrials.gov