Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Overview

The aim of this study was to compare the therapeutic efficacy of lipoic acid versus progesterone by vaginal administration on subchorionic hematoma resorption in women at the first trimester of pregnancy with threatened miscarriage.

Full Title of Study: “Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2015

Interventions

  • Device: Lipoic acid
    • Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)
  • Drug: Progesterone
    • Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)

Arms, Groups and Cohorts

  • Experimental: Lipoic acid
    • vaginal capsules of lipoic acid (10 mg, one capsule per day)
  • Active Comparator: Progesterone
    • Vaginal soft gel of progesterone (200 mg, two capsules per day)

Clinical Trial Outcome Measures

Primary Measures

  • Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination
    • Time Frame: T1 (20 days); T2 (40 days)
    • The evaluation of the hematoma significance is done comparing its size with that one of the gestational sac during the ultrasound examination. Changes in hematoma resorption (% improvement/ worsening) during the treatment were obtained for each patient by calculating the Δ percentage between two subsequent time points.

Secondary Measures

  • Number of participants with abdominal pain as assessed by questionnaire
    • Time Frame: T1 (20 days)
  • Number of participants with vaginal bleeding as assessed by questionnaire
    • Time Frame: T1 (20 days)
  • Number of participants with abdominal pain as assessed by questionnaire
    • Time Frame: T2 (40 days)
    • Questionaire
  • Number of participants with vaginal bleeding as assessed by questionnaire
    • Time Frame: T2 (40 days)
  • Number of participants who miscarried as assessed by ultrosound examination
    • Time Frame: 20 weeks of gestation

Participating in This Clinical Trial

Inclusion Criteria

  • Age: 24-37 – Gestational week: 7- 12 – Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding) – Ultrasound evidence of subchorionic hematoma Exclusion Criteria:

  • Lack of fetus – Absence of fetal heart tone – Uterine anomaly or fetal anomaly – Presence of multiple pregnancy – Gestation pathology – Therapies with anti-coagulants or anti-hypertensive drugs

Gender Eligibility: Female

Minimum Age: 24 Years

Maximum Age: 37 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda USL Ferrara
  • Provider of Information About this Clinical Study
    • Principal Investigator: Demetrio Costantino, Medical Doctor – Azienda USL Ferrara

References

Yassaee F, Shekarriz-Foumani R, Afsari S, Fallahian M. The effect of progesterone suppositories on threatened abortion: a randomized clinical trial. J Reprod Infertil. 2014 Jul;15(3):147-51.

Porcaro G, Brillo E, Giardina I, Di Iorio R. Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results. Eur Rev Med Pharmacol Sci. 2015 Sep;19(18):3426-32.

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