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Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

Primary Purpose

Subchorionic Hematoma in the First Trimester Pregnancy, Miscarriage

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Lipoic acid
Progesterone
Sponsored by
Azienda USL Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subchorionic Hematoma in the First Trimester Pregnancy

Eligibility Criteria

24 Years - 37 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Azienda USL Ferrara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lipoic acid

Progesterone

Arm Description

vaginal capsules of lipoic acid (10 mg, one capsule per day)

Vaginal soft gel of progesterone (200 mg, two capsules per day)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with abdominal pain as assessed by questionnaire
Number of participants with vaginal bleeding as assessed by questionnaire
Number of participants with abdominal pain as assessed by questionnaire
Questionaire
Number of participants with vaginal bleeding as assessed by questionnaire
Number of participants who miscarried as assessed by ultrosound examination

Full Information

First Posted
November 6, 2015
Last Updated
January 7, 2016
Sponsor
Azienda USL Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT02601898
Brief Title
Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment
Official Title
Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL Ferrara

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subchorionic Hematoma in the First Trimester Pregnancy, Miscarriage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lipoic acid
Arm Type
Experimental
Arm Description
vaginal capsules of lipoic acid (10 mg, one capsule per day)
Arm Title
Progesterone
Arm Type
Active Comparator
Arm Description
Vaginal soft gel of progesterone (200 mg, two capsules per day)
Intervention Type
Device
Intervention Name(s)
Lipoic acid
Intervention Description
Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)
Primary Outcome Measure Information:
Title
Change in subchorionic hematoma from baseline at 20 days and 40 days, assessed as %improvement/worsening by ultrasoud examination
Description
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 Outcome Measure Information:
Title
Number of participants with abdominal pain as assessed by questionnaire
Time Frame
T1 (20 days)
Title
Number of participants with vaginal bleeding as assessed by questionnaire
Time Frame
T1 (20 days)
Title
Number of participants with abdominal pain as assessed by questionnaire
Description
Questionaire
Time Frame
T2 (40 days)
Title
Number of participants with vaginal bleeding as assessed by questionnaire
Time Frame
T2 (40 days)
Title
Number of participants who miscarried as assessed by ultrosound examination
Time Frame
20 weeks of gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Azienda USL Ferrara
City
Ferrara
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25202672
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.
Results Reference
background
PubMed Identifier
26439038
Citation
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.
Results Reference
background
PubMed Identifier
27160142
Citation
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.
Results Reference
derived

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Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment

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