NCT02601898

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

November 6, 2015

Last Update Submit

January 7, 2016

Conditions

Subchorionic Hematoma in the First Trimester PregnancyMiscarriage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

    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

Study Arms (2)

Lipoic acid

EXPERIMENTAL

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

Device: Lipoic acid

Progesterone

ACTIVE COMPARATOR

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

Drug: Progesterone

Interventions

Lipoic acidDEVICE

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

Lipoic acid
ProgesteroneDRUG

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

Progesterone

Eligibility Criteria

Age24 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 24-37
  • Gestational week: 7- 12
  • Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
  • Ultrasound evidence of subchorionic hematoma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda USL Ferrara

Ferrara, Italy

Location

Related Publications (3)

  • 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.

    PMID: 25202672BACKGROUND

  • 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.

    PMID: 26439038BACKGROUND

  • 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.

    PMID: 27160142DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 11, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

IT(1)