PregnancySerenaNCT01465867
Selenium Supplementation in Pregnancy
A study testing Selenium and Selenium + L-Thyroxine (LT4) in people with Pregnancy and Infertility, run by University of Roma La Sapienza at 11 sites in Italy.
Trial summary
Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab) autoantibodies are strongly associated with an increased risk of miscarriage and premature deliveries in euthyroid pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Pregnancy, Infertility, Auto-immune Thyroiditis
- What is being tested?
- Selenium and Selenium + L-Thyroxine (LT4)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 11 sitesItaly
- Study dates
- Apr 2012to Jan 2018
- Phase
- Interventional
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with 10°± 2 weeks of gestation
- women in whom embryo transfer is expected within 60 days
- euthyroid women (0.4 μIU/ml < TSH < 2.5 μIU/ml), positive for TPOab and/or TgAb, not assuming LT4 replacement
- euthyroid women (0.4 μIU/ml < TSH < 2.5 μIU/ml), positive for TPOab and/or TgAb under LT4 replacement (to maintain TSH within the control range).
- women with TSH > 2.5 μIU/ml positive for TPOab and/or TgAb, not assuming LT4 replacement (requiring the beginning of LT4 replacement)
- women with TSH > 2.5 μIU/ml positive for TPOab and/or TgAb, under LT4 replacement (requiring an adjustment of LT4 replacement)
Who cannot join
- use of dietary supplements containing selenium in the previous 4 months;
- use of antidepressive/psychotic drugs, amiodarone, propanolol, lithium, cytokines;
- history of hyperthyroidism positive anti-thyrotropin ab;
- previous partial or total thyroidectomy;
- known fetal anomaly;
- known infections (PID, HIV, HCV) and mola hydatidoses;
Show all 13Show fewer
- chronic renal failure;
- uncontrolled hypertension;
- uterine malformation;
- history of medical and metabolic complication such as heart disease or diabetes;
- previous embryo transfer failed within last 3 months;
- miscarriage within last 3 months;
- gestational diabetes in previous pregnancies.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Azienda ospedaliero-universitaria Careggi
Florence, 50134
Istituto Auxologico Italiano
Milan, 20095
Ospedale Maggiore Policlinico
Milan, 20122
University Federico II
Naples, 80131
University "Piemonte Orientale, A. Avogadro"
Novara, 28100
Torvergata University of Rome - Ospedale S. Eugenio
Rome, 00145
European Hospital
Rome, 00148
Ospedale S. Giovanni Calibita Fatebenefratelli
Rome, 00153
Department of Experimental Medicine, "Sapienza" University of Rome
Rome, 00161
Department of Gynecological/Obstetric/Urological Sciences, "Sapienza" University of Rome
Rome, 00161
Dpt of Experimental Medicine
Rome, 00161
About this study
Official title: Selenium Supplementation Treatment in Euthyroid Pregnant Women With Autoimmune Thyroid Disease: Effects on Obstetrical Complications
Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab) autoantibodies are strongly associated with an increased risk of miscarriage and premature deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other supplementations in euthyroid-Ab positivity during pregnancy has not been established. The development of a safe and effective intervention that modulates inappropriate inflammatory responses could be a very important component of prevention against adverse health outcomes during pregnancy.
The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in Se-non-deficient patients with autoimmune thyroiditis (AIT).
Read more
The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and hypothyroidism.
Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been implicated in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.
The purpose of the present study is performed to establish the effect of Se supplementation in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60 days) on Ab trend, thyroid function and structure, implantation rates, pregnancy rates, pregnancy outcome and number of obstetrical, fetal and neonatal complications.
Read the detailed description
Adverse outcomes, postpartum thyroid dysfunction and permanent hypothyroidism have been associated with isolated TPOab positivity in euthyroid pregnant women.
In areas with severe selenium deficiency there is a higher incidence of thyroiditis due to a decreased activity of selenium-dependent glutathione peroxidase activity within thyroid cells. Selenium-dependent enzymes also have several modifying effects on the immune system. Therefore, even mild selenium deficiency may contribute to the development and maintenance of autoimmune thyroid diseases.
Selenium substitution exerts anti-inflammatory and anti-oxidant activities. Se could represents an important supplementation in euthyroid women with AIT in order to improve thyroid function and structure and to prevent obstetrical adverse events related to autoimmune diseases and reactive oxygen species, such as recurrent miscarriage and pre-eclampsia.
The aim of this study is to document the effects of Selenium Supplementation with and without L-thyroxine (LT4) in euthyroid women with AIT, during pregnancy.
This protocol will evaluate the trend of TPOab and Tgab, selenium concentration, thyroid volume and echogenicity, nodule formation and number of adverse effects that affect the mother (during and after pregnancy), the fetus, the infant and the heath service, needing to elucidate the nature of the emerging associations.
The study also aims to assess the impact of Selenium Supplementation on implantation rate and pregnancy rate in women with transfer planned within the next 60 days.
This is designed as a phase IV study on treatment with a cohort size of pregnant women and women in whom embryo transfer is expected within 60 days with TSH value into the normal range (0.4-2.5 mUI/mL) and Tgab and/or TPOab positivity. We have performed two randomizations arms: Randomization arm A will include women LT4 replacement-free that will take Selenium or Placebo and Randomization arm B will include women already under LT4 replacement that will take Selenium or Placebo. Patients included in Randomization A will move into Randomization B, if TSH increases above 2.5 mUI/mL during pregnancy.
Pregnant women with TSH > 2.5 mU/mL at time 0 will begin (or will adjust) LT4 replacement and will be included in Randomization arm B.
Accounting for a 30% drop off, a total enrolment of 150 patients is planned. Patients will be randomized at time 0 (10°± 2 weeks of gestation). Follow-up visits will take place at weeks 14 ± 2, 24 ± 2, 32 ± 2, 36 ± 2 weeks, and between months 3° and 6° after labour. An optional visit could be done 12 months after labor. Plasma and serum monitoring of thyroid hormones, Tgab, TPOab, Se concentration, Selenoproteins and cytokines, thyroid US, SF12 questionnaire will be made at all the follow-up visits. At visit 3 (24 ± 2 weeks) patients will optionally do the OGTT). Gestational, obstetrical, maternal, fetal, and infant anamnestic data will be taken, during the follow up visits and at labour.
The long-term objective is to identify a safe and easily administered supplementation that improves:
- implantation and pregnancy rates in infertile women Tgab and/or TPOab positives
- maternal and fetal complication in pregnant euthyroid women Tgab and/or TPOab positives.
- Conditions
- Pregnancy, Infertility, Auto-immune Thyroiditis
- Being tested
- Selenium, Sugar Pill Placebo, Selenium + L-Thyroxine (LT4), Sugar Pill Placebo + L-Thyroxine (LT4)
- Keywords
- Selenium, Pregnancy, Auto-immune thyroiditis, Post-partum thyroiditis, Miscarriage, Pre-eclampsia, Implantation and Pregnancy rate, Infertility
- Medical subject headings
- Infertility, Postpartum Thyroiditis, Abortion, Spontaneous, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
Also called Intervention I (Se)
83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour
Sugar Pill PlaceboOther
Also called Intervention II (Plb)
Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour.
Selenium + L-Thyroxine (LT4)Other
Also called Intervention III (Se+LT4)
83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour
+ LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)
Sugar Pill Placebo + L-Thyroxine (LT4)Other
Also called Intervention IV (Plb + LT4)
Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour
+ LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)
| Study group | Role | What they receive |
|---|---|---|
| Selenium | Experimental | Not described Receives: Dietary Supplement: Selenium |
| Sugar Pill Placebo | Placebo comparator | Not described Receives: Other: Sugar Pill Placebo |
| Selenium + L-Thyroxine (LT4) | Experimental | Not described Receives: Other: Selenium + L-Thyroxine (LT4) |
| Sugar Pill Placebo + L-Thyroxine (LT4) | Experimental | Not described Receives: Other: Sugar Pill Placebo + L-Thyroxine (LT4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in TPOab and/or Tgab
TPOab and Tgab titers will be measured using a ECLIA kit. Plasma selenium concentration will also be measured
Measured: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Secondary outcomes (8)
Changes in thyroid volume and echogenicity
Also changes in thyroid nodules diameters and/or nodules formation will be measured by Ultrasonographic (US) imaging
Measured: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Changes in thyroid hormones (TSH, FT4, FT3)
Measured: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Evaluation of Maternal risks
Pre-eclampsia (gestational hypertension: systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation), Miscarriage, Placental Abruption, Abruption, Gestational hypertension, Breech presentation at birth, Preterm birth (< 37 weeks gestation), Symptomatic hypothyroidism, Preterm labour, Postpartum haemorrhage, Postpartum depression, Postpartum Thyroiditis, Maternal death
Measured: From the date of randomization until the date of first documented event
Evaluation of Infant risks
Small for gestational age, Admission to special care, Cretinism, Jaundice requiring phototherapy, Poor feeding, Constipation, Hoarse cry, Lethargy, Hypotonia, Macroglossia, Umbilical hernia
Measured: From the date of labour until the date of the first documented event
Changes in of quality of life
Quality of life will be measured by questionnaire SF12
Measured: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Evaluation of Health Services:
Maternal length of hospital stay (days), Neonatal length of hospital stay (in days), Cost of services
Measured: from the date of admission until the date of discharge
Changes in the selenium-dependent antioxidant enzyme glutathione peroxidase
Glucose, Vitamin B-12, folate, methionine, albumin and cytokines will be also measured in serum
Measured: 0, 24 ± 2, 36± 2 weeks; and 6 months after labour
Changes in implantation and pregnancy rates
Clinical implantation rate (IR) and pregnancy rate (PR)
Measured: From the date of embryo transfer until the date of documented progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionJun 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Isidori, University of Roma La Sapienza
- Investigators
- Andrea M Isidori, MD, PhD, Principal investigator, Department of Experimental Medicine, Section of Clinical Pathophysiology and Endocrinology, "Sapienza" University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465867
- Sponsor's protocol ID
- Sel-01
- Acronym
- Serena
- Status last verified
- Jan 2018
- First submitted
- 2 Nov 2011
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium Supplementation Treatment in Euthyroid Pregnant Women With Autoimmune Thyroid Disease: Effects on Obstetrical Complications
- ClinicalTrials.gov ID
- NCT01465867
- Acronym / sponsor ID
- Serena / Sel-01
- Conditions
- Pregnancy, Infertility, Auto-immune Thyroiditis
- Keywords
- Selenium, Pregnancy, Auto-immune thyroiditis, Post-partum thyroiditis, Miscarriage, Pre-eclampsia, Implantation and Pregnancy rate, Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Nov 2011 (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.
Serum levels of isolated anti-thyroperoxidase (TPOab) and anti-thyreoglobulin (Tgab) autoantibodies are strongly associated with an increased risk of miscarriage and premature deliveries in euthyroid pregnant women. Replacement of thyroxine (LT4) or other supplementations in euthyroid-Ab positivity during pregnancy has not been established. The development of a safe and effective intervention that modulates inappropriate inflammatory responses could be a very important component of prevention against adverse health outcomes during pregnancy.
The anti-oxidant Selenium (Se) suppresses autoimmune destruction of thyrocytes and at daily dose of 200 mcg and 100 mcg decreases titers of serum TPOAb and TgAb also in Se-non-deficient patients with autoimmune thyroiditis (AIT).
The use of Se in AIT has been shown to reduce the incidence of postpartum thyroiditis and hypothyroidism.
Women with recurrent pregnancy loss had lower Se levels and Se deficiency has been implicated in the pathogenesis of AIT and in the impairment of T/B cell-mediated immunity.
The purpose of the present study is performed to establish the effect of Se supplementation in euthyroid women with AIT (pregnant and in whom embryo transfer is expected within 60 days) on Ab trend, thyroid function and structure, implantation rates, pregnancy rates, pregnancy outcome and number of obstetrical, fetal and neonatal complications.
Detailed description
Adverse outcomes, postpartum thyroid dysfunction and permanent hypothyroidism have been associated with isolated TPOab positivity in euthyroid pregnant women.
In areas with severe selenium deficiency there is a higher incidence of thyroiditis due to a decreased activity of selenium-dependent glutathione peroxidase activity within thyroid cells. Selenium-dependent enzymes also have several modifying effects on the immune system. Therefore, even mild selenium deficiency may contribute to the development and maintenance of autoimmune thyroid diseases.
Selenium substitution exerts anti-inflammatory and anti-oxidant activities. Se could represents an important supplementation in euthyroid women with AIT in order to improve thyroid function and structure and to prevent obstetrical adverse events related to autoimmune diseases and reactive oxygen species, such as recurrent miscarriage and pre-eclampsia.
The aim of this study is to document the effects of Selenium Supplementation with and without L-thyroxine (LT4) in euthyroid women with AIT, during pregnancy.
This protocol will evaluate the trend of TPOab and Tgab, selenium concentration, thyroid volume and echogenicity, nodule formation and number of adverse effects that affect the mother (during and after pregnancy), the fetus, the infant and the heath service, needing to elucidate the nature of the emerging associations.
The study also aims to assess the impact of Selenium Supplementation on implantation rate and pregnancy rate in women with transfer planned within the next 60 days.
This is designed as a phase IV study on treatment with a cohort size of pregnant women and women in whom embryo transfer is expected within 60 days with TSH value into the normal range (0.4-2.5 mUI/mL) and Tgab and/or TPOab positivity. We have performed two randomizations arms: Randomization arm A will include women LT4 replacement-free that will take Selenium or Placebo and Randomization arm B will include women already under LT4 replacement that will take Selenium or Placebo. Patients included in Randomization A will move into Randomization B, if TSH increases above 2.5 mUI/mL during pregnancy.
Pregnant women with TSH > 2.5 mU/mL at time 0 will begin (or will adjust) LT4 replacement and will be included in Randomization arm B.
Accounting for a 30% drop off, a total enrolment of 150 patients is planned. Patients will be randomized at time 0 (10°± 2 weeks of gestation). Follow-up visits will take place at weeks 14 ± 2, 24 ± 2, 32 ± 2, 36 ± 2 weeks, and between months 3° and 6° after labour. An optional visit could be done 12 months after labor. Plasma and serum monitoring of thyroid hormones, Tgab, TPOab, Se concentration, Selenoproteins and cytokines, thyroid US, SF12 questionnaire will be made at all the follow-up visits. At visit 3 (24 ± 2 weeks) patients will optionally do the OGTT). Gestational, obstetrical, maternal, fetal, and infant anamnestic data will be taken, during the follow up visits and at labour.
The long-term objective is to identify a safe and easily administered supplementation that improves:
- implantation and pregnancy rates in infertile women Tgab and/or TPOab positives
- maternal and fetal complication in pregnant euthyroid women Tgab and/or TPOab positives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Selenium | Experimental | Dietary Supplement: Selenium |
| Sugar Pill Placebo | Placebo comparator | Other: Sugar Pill Placebo |
| Selenium + L-Thyroxine (LT4) | Experimental | Other: Selenium + L-Thyroxine (LT4) |
| Sugar Pill Placebo + L-Thyroxine (LT4) | Experimental | Other: Sugar Pill Placebo + L-Thyroxine (LT4) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- pregnant women with 10°± 2 weeks of gestation
- women in whom embryo transfer is expected within 60 days
- euthyroid women (0.4 μIU/ml < TSH < 2.5 μIU/ml), positive for TPOab and/or TgAb, not assuming LT4 replacement
- euthyroid women (0.4 μIU/ml < TSH < 2.5 μIU/ml), positive for TPOab and/or TgAb under LT4 replacement (to maintain TSH within the control range).
- women with TSH > 2.5 μIU/ml positive for TPOab and/or TgAb, not assuming LT4 replacement (requiring the beginning of LT4 replacement)
Key exclusion criteria (13 listed)
- use of dietary supplements containing selenium in the previous 4 months;
- use of antidepressive/psychotic drugs, amiodarone, propanolol, lithium, cytokines;
- history of hyperthyroidism positive anti-thyrotropin ab;
- previous partial or total thyroidectomy;
- known fetal anomaly;
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 |
|---|---|---|
| SeleniumAlso: Intervention I (Se)83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour | Dietary supplement | Selenium |
| Sugar Pill PlaceboAlso: Intervention II (Plb)Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour. | Other | Sugar Pill Placebo |
| Selenium + L-Thyroxine (LT4)Also: Intervention III (Se+LT4)83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour + LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it) | Other | Selenium + L-Thyroxine (LT4) |
| Sugar Pill Placebo + L-Thyroxine (LT4)Also: Intervention IV (Plb + LT4)Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour + LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it) | Other | Sugar Pill Placebo + L-Thyroxine (LT4) |
Primary outcome
Changes in TPOab and/or Tgab
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
TPOab and Tgab titers will be measured using a ECLIA kit. Plasma selenium concentration will also be measured
8 secondary outcomes
Changes in thyroid volume and echogenicity
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Changes in thyroid hormones (TSH, FT4, FT3)
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Evaluation of Maternal risks
Time frame: From the date of randomization until the date of first documented event
Evaluation of Infant risks
Time frame: From the date of labour until the date of the first documented event
Changes in of quality of life
Time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour
Evaluation of Health Services:
Time frame: from the date of admission until the date of discharge
Changes in the selenium-dependent antioxidant enzyme glutathione peroxidase
Time frame: 0, 24 ± 2, 36± 2 weeks; and 6 months after labour
Changes in implantation and pregnancy rates
Time frame: From the date of embryo transfer until the date of documented progression
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 30 Jan 2018.
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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.
Andrea M Isidori, MD, PhD principal investigator
Department of Experimental Medicine, Section of Clinical Pathophysiology and Endocrinology, "Sapienza" University of Rome
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium and Selenium + L-Thyroxine (LT4) in people with Pregnancy and Infertility, run by University of Roma La Sapienza at 11 sites 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 6 inclusion and 13 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in TPOab and/or Tgab (time frame: 0 and 14 ± 2, 24 ± 2, 32± 2, 36± 2 weeks; and between 3° and 6° month after labour; and optionally 12° after labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2018.