Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601898
• Other study ID #: ALAvsPROG
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2015
• Last updated: January 7, 2016
• Start date: January 2015

Study information

• Verified date: January 2016
• Source: Azienda USL Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 37 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematoma
• Miscarriage
• Subchorionic Hematoma in the First Trimester Pregnancy

Intervention

Device:
• Lipoic acid
Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)

Drug:
• Progesterone
Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)

Locations

Country	Name	City	State
Italy	Azienda USL Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? percentage between two subsequent time points.	T1 (20 days); T2 (40 days)
Secondary	Number of participants with abdominal pain as assessed by questionnaire		T1 (20 days)
Secondary	Number of participants with vaginal bleeding as assessed by questionnaire		T1 (20 days)
Secondary	Number of participants with abdominal pain as assessed by questionnaire	Questionaire	T2 (40 days)
Secondary	Number of participants with vaginal bleeding as assessed by questionnaire		T2 (40 days)
Secondary	Number of participants who miscarried as assessed by ultrosound examination		20 weeks of gestation