SUBCLINICAL HYPOTHYROIDISM DURING PREGNANCY MedDRA version: 20.0 Level: LLT Classification code 10000560 Term: Acquired hypothyroidism other System Organ Class: 100000004860
Conditions
Interventions
Trade Name: TICHE - "25 MICROGRAMMI CAPSULE MOLLI" 30 CAPSULE IN BLISTER PVC-PCTFE/AL
Product Name: TICHE
Pharmaceutical Form: Capsule, soft
Trade Name: TICHE - "50 MICROGRAMMI CAPSULE MOLLI" 30 CAPS
Sponsors
A.O. OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult pregnant women (> 18 years) • First trimester of pregnancy • Subclinical hypothyroidism diagnosed during pregnancy; autoimmune, or in absence of thyroidal autoimmunity; treated with levothyroxine, or not treated • Subclinical hypothyroidism diagnosed before pregnancy; autoimmune, or in absence of thyroidal autoimmunity; treated with levothyroxine, or not treated • Nausea/vomiting of the pregnancy (mild to moderate) • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Intolerance to levothyroxine or to any Tiche excipient • Inability to swallow • Pregnancy developed by medically assisted procreation • Twin pregnancy • Premature aberrations of the fetal growht (first trimester) • Patients with post-surgical primitive hypothyroidism (due to total thyroidectomy) • Patients with post-131I radiotherapy primitive hypothyroidism • Patients pre-gestationally affected by: severe obesity (BMI > 40 kg/m2), diabetes, heart diseases, chronic atrophic gastritis, celiac disease, inflammatory bowel diseases • Concomitant treatments not allowed • Patients that underwent gastro-intestinal surgery with malabsorption • Inability to give an informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Dosage of Tiche necessary to obtain the therapeutic target (TSH < 2.5 mcU/ml) at the eight month of pregnancy in the treatment group.;Secondary Objective: - Dosage of Tiche necessary to obtain the therapeutic target (TSH < 2.5 mcU/ml) at the fifth month of pregnancy in the treatment group. - Evaluation of perceived quality of life during pregnancy.;Primary end point(s): Dosage of Tiche (mcg/kg/die) in the treatment group, versus dosage of Tiche (mcg/kg/die) in the control group necessary to obtain the therapeutic target at the eight month of pregnancy.;Timepoint(s) of evaluation of this end point: 8th month of pregnancy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Dosage of Tiche (mcg/kg/die) in the treatment group, versus dosage of Tiche (mcg/kg/die) in the control group necessary to obtain the therapeutic target at the fifth month of pregnancy.; Percentage of patients with improved QoL in the treatment group.;Timepoint(s) of evaluation of this end point: 5th month of pregnancy; 5th and 8th month of pregnancy | — |
Countries
Italy
Contacts
Public ContactSegreteria Tecnico-Scientifica CE
ASST SETTE LAGHI - Ospedale di Circolo e Fondazione Macchi
Outcome results
None listed