Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02601898

Enrollment

Registered

2015-11-11

Start date

2015-01-31

Completion date

Unknown

Last updated

2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subchorionic Hematoma in the First Trimester Pregnancy, Miscarriage

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.

Interventions

DEVICELipoic acid

Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)

DRUGProgesterone

Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

24 Years to 37 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination	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

Measure	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 who miscarried as assessed by ultrosound examination	20 weeks of gestation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026