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OpenTrials
Completed

NCT Number: NCT02601898

Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

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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Key information

Conditions

Subchorionic Hematoma in the First Trimester Pregnancy Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Miscarriage Pregnancy Complications Urogenital Diseases

Age range

24 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Azienda USL Ferrara

Ferrara, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lipoic acid

Device

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

Progesterone

Drug

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

Primary outcomes

  1. Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination

    Time frame: 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 outcomes

  1. Number of participants with abdominal pain as assessed by questionnaire

    Time frame: T1 (20 days)

  2. Number of participants with vaginal bleeding as assessed by questionnaire

    Time frame: T1 (20 days)

  3. Number of participants with abdominal pain as assessed by questionnaire

    Time frame: T2 (40 days)

    Questionaire

  4. Number of participants with vaginal bleeding as assessed by questionnaire

    Time frame: T2 (40 days)

  5. Number of participants who miscarried as assessed by ultrosound examination

    Time frame: 20 weeks of gestation

Sponsors and collaborators

Lead sponsor

Azienda USL Ferrara

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
First posted
Nov 11, 2015
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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