Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment

Conditions
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Subchorionic Hematoma in the First Trimester Pregnancy, Miscarriage

Intervention / Treatment
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* Device: Lipoic acid
* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipoic acid<br>vaginal capsules of lipoic acid (10 mg, one capsule per day) | Device: Lipoic acid<br>* Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)<br>|
| Active Comparator: Progesterone<br>Vaginal soft gel of progesterone (200 mg, two capsules per day) | Drug: Progesterone<br>* Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 |