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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipoic acid | Experimental | vaginal capsules of lipoic acid (10 mg, one capsule per day) |
|
| Progesterone | Active Comparator | Vaginal soft gel of progesterone (200 mg, two capsules per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipoic acid | Device | Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination | 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. | T1 (20 days); T2 (40 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with abdominal pain as assessed by questionnaire | T1 (20 days) | |
| Number of participants with vaginal bleeding as assessed by questionnaire | T1 (20 days) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda USL Ferrara | Ferrara | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25202672 | Background | 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. | |
| 26439038 | Background | 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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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Progesterone | Drug | Vaginal capsules (drug) containing 200 mg of progesterone (2 per day) |
|
| Number of participants with abdominal pain as assessed by questionnaire |
Questionaire |
| T2 (40 days) |
| Number of participants with vaginal bleeding as assessed by questionnaire | T2 (40 days) |
| Number of participants who miscarried as assessed by ultrosound examination | 20 weeks of gestation |
| 27160142 | Derived | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |