Pilot Randomized Controlled Trial of Vaginal Progesterone to Prevent Preterm Birth in Women With Threatened Preterm Labor

Study Identifier:
21492
CT.gov Identifier:
NCT01286246
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

Considering participating in a START clinical trial?

Get Started

Study Summary

Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor.

Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in.

Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment.

When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    IV
    Sex
    Female
    Age
    18 - 50 Years
    Study Drug
  • Drug: Experimental: Vaginal progesterone
    • Read More
  • Drug: Placebo Comparator: Placebo
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • * Women with symptomatic premature contractions successfully arrested for at least 12 hours with tocolytics.
    • * Women with symptoms suggestive of early preterm labor whose contractions resolve without tocolysis but are fetal fibronectin positive.
    • * Gestational age 23(+0)-32(+6) weeks.
    • * Consent to taking part in the study.
    Exclusion criteria
    • * Placenta previa
    • * Preterm premature rupture of membranes at presentation
    • * Pre-existing hypertension will be excluded in order to reduce the likelihood of iatrogenic preterm delivery within the study women
    • * Known major fetal anomaly detected on ultrasound
    • * Multiple pregnancy
    • * Maternal seizure disorder
    • * Active or history of thromboembolic disease
    • * Maternal liver disease
    • * Known or suspected breast malignancy or pathology
    • * Known or suspected progesterone-dependent neoplasia
    • * Plans to move to another city during pregnancy
    • * Previous participation in a progesterone trial during this pregnancy
    • * Known sensitivity to progesterone

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate