Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Vaginal Administration of Alpha Lipoic Acid 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.

Study Overview

• Status: Completed
• Conditions: Miscarriage; Subchorionic Hematoma in the First Trimester Pregnancy
• Intervention / Treatment: Device: Lipoic acid; Drug: Progesterone

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy
    • Azienda USL Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda USL Ferrara

Publications and helpful links

General Publications

• Yassaee F, Shekarriz-Foumani R, Afsari S, Fallahian M. The effect of progesterone suppositories on threatened abortion: a randomized clinical trial. J Reprod Infertil. 2014 Jul;15(3):147-51.
• Porcaro G, Brillo E, Giardina I, Di Iorio R. Alpha Lipoic Acid (ALA) effects on subchorionic hematoma: preliminary clinical results. Eur Rev Med Pharmacol Sci. 2015 Sep;19(18):3426-32.
• Costantino M, Guaraldi C, Costantino D. Resolution of subchorionic hematoma and symptoms of threatened miscarriage using vaginal alpha lipoic acid or progesterone: clinical evidences. Eur Rev Med Pharmacol Sci. 2016 Apr;20(8):1656-63.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Pregnancy Complications; Abortion, Spontaneous; Hematoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Progestins; Progesterone; Thioctic Acid
• Other Study ID Numbers: ALAvsPROG