T4Life trial.

Recruiting

Conditions: <p>Recurrent miscarriage Thyroid auto-immunity Live birth rate Levothyroxine</p>

Registration Number: NL-OMON20417

Lead Sponsor: Academic Medical Centre

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

1. Women with RM and thyroid autoimmunity. Recurrent miscarriage is defined as two or more miscarriages. TPOAb positivity is defined as euthyroid with presence of TPO antibodies. This will be defined according to the cut off levels of the coordinating or cooperating centres. Most commonly used are cut off levels from 60 kU/l or 100kU/l;

2. Age 18 - 42 years at randomisation;

Exclusion Criteria

1. Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies IgG or IgM);

2. Other auto-immune conditions, diabetes mellitus, diabetes gravidarum, thyroid disease different then isolated thyroid autoimmunity;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Live birth beyond 24 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Miscarriage rate; 2. Any adverse pregnancy complications (preterm birth, preeclampsia, gestational diabetes, intrauterine growth retardation, pregnancy induced hypertension, birth weight, placental abruption, placenta praevia, perinatal mortality, mode of delivery, respiratory distress, low Apgar scores, admission NICU, breech position, neonatal thyroid dysfunction and malformations, postpartum thyroid disease); 3. Time to pregnancy (defined as the interval between thyroid function test and the month of conception of the next pregnancy).</p><br>