Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Azienda USL Ferrara

Status and phase: Completed; Phase 4

Conditions: Subchorionic Hematoma in the First Trimester Pregnancy; Miscarriage

Treatments: Device: Lipoic acid; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02601898

ALAvsPROG

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: Female

Ages: 24 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Lipoic acid

Experimental group

Description:

vaginal capsules of lipoic acid (10 mg, one capsule per day)

Treatment:

Device: Lipoic acid

Progesterone

Active Comparator group

Description:

Vaginal soft gel of progesterone (200 mg, two capsules per day)

Treatment:

Drug: Progesterone