Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment
NCT ID: NCT02601898
Last Updated: 2016-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lipoic acid
vaginal capsules of lipoic acid (10 mg, one capsule per day)
Lipoic acid
Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)
Progesterone
Vaginal soft gel of progesterone (200 mg, two capsules per day)
Progesterone
Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)
Interventions
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Lipoic acid
Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)
Progesterone
Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)
Eligibility Criteria
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Inclusion Criteria
* Gestational week: 7- 12
* Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
* Ultrasound evidence of subchorionic hematoma
Exclusion Criteria
* Absence of fetal heart tone
* Uterine anomaly or fetal anomaly
* Presence of multiple pregnancy
* Gestation pathology
* Therapies with anti-coagulants or anti-hypertensive drugs
24 Years
37 Years
FEMALE
No
Sponsors
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Azienda USL Ferrara
OTHER_GOV
Responsible Party
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Demetrio Costantino
Medical Doctor
Locations
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Azienda USL Ferrara
Ferrara, , Italy
Countries
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References
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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.
Costantino M, Guaraldi C, Costantino D. Resolution of subchorionic hematoma and symptoms of threatened miscarriage using vaginal alpha lipoic acid or progesterone: clinical evidences. Eur Rev Med Pharmacol Sci. 2016 Apr;20(8):1656-63.
Other Identifiers
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ALAvsPROG
Identifier Type: -
Identifier Source: org_study_id
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