Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Azienda USL Ferrara54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Subchorionic Hematoma in the First Trimester Pregnancy Miscarriage

Interventions

Lipoic acidDEVICE

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

ProgesteroneDRUG

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

Eligibility

Sex: FEMALEMin age: 24 YearsMax age: 37 Years

Medical Language ↔ Plain English

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

Locations (1)

Azienda USL Ferrara

Ferrara, Italy

Outcomes

Primary Outcomes

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.

Time frame: T1 (20 days); T2 (40 days)

Secondary Outcomes

Number of participants with abdominal pain as assessed by questionnaire

Time frame: T1 (20 days)

Number of participants with vaginal bleeding as assessed by questionnaire

Time frame: T1 (20 days)

Number of participants with abdominal pain as assessed by questionnaire

Questionaire

Time frame: T2 (40 days)

Number of participants with vaginal bleeding as assessed by questionnaire

Time frame: T2 (40 days)

Number of participants who miscarried as assessed by ultrosound examination

Time frame: 20 weeks of gestation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.