Subchorionic Hematoma in the First Trimester PregnancyPhase 4NCT02601898
Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment
A Phase 4 study testing Lipoic acid and Progesterone in people with Subchorionic Hematoma in the First Trimester Pregnancy and Miscarriage, run by Azienda USL Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 24 to 37 years, women only
- Conditions the study is for
- Subchorionic Hematoma in the First Trimester Pregnancy, Miscarriage
- What is being tested?
- Lipoic acid and Progesterone
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 24-37
- Gestational week: 7- 12
- Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
- Ultrasound evidence of subchorionic hematoma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Lipoic acid, Progesterone
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoic acidDevice
Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)
ProgesteroneDrug
Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)
| Study group | Role | What they receive |
|---|---|---|
| Lipoic acid | Experimental | vaginal capsules of lipoic acid (10 mg, one capsule per day) Receives: Device: Lipoic acid |
| Progesterone | Active comparator | Vaginal soft gel of progesterone (200 mg, two capsules per day) Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1 (20 days); T2 (40 days)
Secondary outcomes (5)
Number of participants with abdominal pain as assessed by questionnaire
Measured: T1 (20 days)
Number of participants with vaginal bleeding as assessed by questionnaire
Measured: T1 (20 days)
Number of participants with abdominal pain as assessed by questionnaire
Questionaire
Measured: T2 (40 days)
Number of participants with vaginal bleeding as assessed by questionnaire
Measured: T2 (40 days)
Number of participants who miscarried as assessed by ultrosound examination
Measured: 20 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subchorionic Hematoma in the First Trimester PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Ferrara
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Demetrio Costantino, Azienda USL Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601898
- Sponsor's protocol ID
- ALAvsPROG
- Status last verified
- Jan 2016
- First submitted
- 6 Nov 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
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.
PubMed 25202672Porcaro 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.
PubMed 26439038Costantino 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.
PubMed 27160142
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Administration of Alpha Lipoic Acid vs Progesterone for the Subchorionic Hematoma Treatment
- ClinicalTrials.gov ID
- NCT02601898
- Acronym / sponsor ID
- ALAvsPROG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Azienda USL FerraraOther government
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipoic acid | Experimental | Device: Lipoic acidvaginal capsules of lipoic acid (10 mg, one capsule per day) |
| Progesterone | Active comparator | Drug: ProgesteroneVaginal soft gel of progesterone (200 mg, two capsules per day) |
Who may qualify
- Ages
- 24 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 24-37
- Gestational week: 7- 12
- Evidence of threatened miscarriage (pelvic pain with or without vaginal bleeding)
- Ultrasound evidence of subchorionic hematoma
Key exclusion criteria (6 listed)
- Lack of fetus
- Absence of fetal heart tone
- Uterine anomaly or fetal anomaly
- Presence of multiple pregnancy
- Gestation pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipoic acidVaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day) | Device | Lipoic acid |
| ProgesteroneVaginal capsules (drug) containing 200 mg of progesterone (2 per day) | Drug | Progesterone |
Primary outcome
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.
5 secondary outcomes
Number of participants with abdominal pain as assessed by questionnaire
Time frame: T1 (20 days)
Number of participants with vaginal bleeding as assessed by questionnaire
Time frame: T1 (20 days)
Number of participants with abdominal pain as assessed by questionnaire
Time frame: T2 (40 days)
Number of participants with vaginal bleeding as assessed by questionnaire
Time frame: T2 (40 days)
Number of participants who miscarried as assessed by ultrosound examination
Time frame: 20 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Background: PubMed 25202672Yassaee 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.
- Background: PubMed 26439038Porcaro 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.
- Derived from this study: PubMed 27160142Costantino 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipoic acid and Progesterone in people with Subchorionic Hematoma in the First Trimester Pregnancy and Miscarriage, run by Azienda USL Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02601898, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.