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Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

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ClinicalTrials.gov Identifier: NCT02601898
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Demetrio Costantino, Azienda USL Ferrara

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subchorionic Hematoma in the First Trimester Pregnancy Miscarriage Device: Lipoic acid Drug: Progesterone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
Study Start Date : January 2015
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lipoic acid
vaginal capsules of lipoic acid (10 mg, one capsule per day)
Device: Lipoic acid
Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)

Active Comparator: Progesterone
Vaginal soft gel of progesterone (200 mg, two capsules per day)
Drug: Progesterone
Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of participants with abdominal pain as assessed by questionnaire [ Time Frame: T1 (20 days) ]
  2. Number of participants with vaginal bleeding as assessed by questionnaire [ Time Frame: T1 (20 days) ]
  3. Number of participants with abdominal pain as assessed by questionnaire [ Time Frame: T2 (40 days) ]
    Questionaire

  4. Number of participants with vaginal bleeding as assessed by questionnaire [ Time Frame: T2 (40 days) ]
  5. Number of participants who miscarried as assessed by ultrosound examination [ Time Frame: 20 weeks of gestation ]


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Ages Eligible for Study:   24 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02601898


Locations
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Italy
Azienda USL Ferrara
Ferrara, Italy
Sponsors and Collaborators
Azienda USL Ferrara

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Demetrio Costantino, Medical Doctor, Azienda USL Ferrara
ClinicalTrials.gov Identifier: NCT02601898     History of Changes
Other Study ID Numbers: ALAvsPROG
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Progesterone
Hematoma
Abortion, Spontaneous
Hemorrhage
Pathologic Processes
Pregnancy Complications
Thioctic Acid
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances