recurrent miscarriage thyroid autoimmunity
Conditions
Interventions
All women will be randomly allocated to receive either levothyroxie tabelts
once a day taken orally, or receive placebo tablets. Women will start with
medication from the beginning of the study till
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Women with unexplained RM and thyroid autoimmunity. Recurrent miscarriage is defined as two or more miscarriages.TPOAb positivity is defined according to the cut off levels of the coordinating or cooperating centres. 2.Age 18 - 42 years at randomisation 3.Willing and able to give informed consent (IC).
Exclusion criteria
Exclusion criteria: 1.Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM]) and/ or B2-Glycoprotein IgG or IgM) 2.Other auto-immune conditions, diabetes mellitus, diabetes gravidarum, thyroid disease different then isolated thyroid autoimmunity. 3. Abnormal TSH. This is defined as a TSH level different then the centre specific cut- off levels. ( Known thyroid disease different then isolated thyroid autoimmunity) 4.Previous enrolment in the T4LIFE- trial 5. Contraindications to levothyroxine use: Adrenal or pituitary disorders, untreated Thyreotoxicosis, untreated Acute cardiac arrest Acute pancreatitis Acute myocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: live birth rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: ongoing pregnancy at 12 weeks (range 11 - 13 weeks), miscarriage rate (miscarriage defined as pregnancy loss before the 20th week of gestation), preterm delivery (preterm birth defined as delivery before 37 weeks of gestation), survival at 28 days of neonatal life, adverse events, subgroup effects of levothyroxine, postpartum thyroid disease (defined as abnormal TSH levels three or six months postpartum). | — |
Countries
Netherlands
Outcome results
None listed