evothyroxine for recurrent miscarriage

Phase 1

• Conditions: Thyroid autoimmunity is associated with recurrent miscarriage and preterm birth. Thyroid autoimmunity means there is a normal thyroid function, but presence of thyroid antibodies, thyroid peroxidase antibodies (TPO-Ab).; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-001820-39-NL
• Lead Sponsor: Academic medical centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-14
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1.Women with unexplained RM and thyroid autoimmunity. Recurrent miscarriage is defined as two or more miscarriages. TPOAb positivity is defined as a TPO titre higher then 100 kU/ltr or two times higher then 60 kU/ltr.
2.Age 18 - 42 years at randomisation
3.Willing and able to give informed consent (IC).

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 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM])
2. Other auto-immune conditions
3.Previous enrolment in the trial
4. Abnormal TSH levels
5. Contraindications to levothyroxine use:
Adrenal or pituitary disorders, untreated
Thyreotoxicosis, untreated
Acute cardiac arrest
Acute pancreatitis
Acute myocarditis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess improvement in live birth rate after levothyroxine supplementation. <br>Primary outcome measure: live birth rate.;Secondary Objective: To evaluate the effect of levothyroxine supplementation on adverse pregnancy outcomes, like preterm birth. <br>Secondary outcome measures: miscarriage rate, any adverse pregnancy outcomes. ;Primary end point(s): Live birth rate;Timepoint(s) of evaluation of this end point: Evaluation will be at the end of the pregnancy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Miscarriage rate, preterm birth or any other adverse pregnancy outcomes;Timepoint(s) of evaluation of this end point: Evaluation will be at the end of the pregnancy