T4Life trial.

Levothyroxine for euthyroid women with recurrent miscarriage and positive TPO antibodies: A randomized controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20417

Enrollment

240

Registered

2012-03-21

Start date

2013-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent miscarriage Thyroid auto-immunity Live birth rate Levothyroxine

Interventions

Levothyroxine tablets started preconceptually after diagnostic work up for recurrent miscarriage till the end of the next pregnancy.

Eligibility

Inclusion criteria

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; 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); 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; 4. Previous enrolment in the T4LIFE-trial; 5. Contraindications to levothyroxine use: Adrenal or pituitary disorders, untreated Acute cardiac arrest; 6. Acute pancreatitis; 7. Acute myocarditis.

Design outcomes

Primary

Measure	Time frame
Live birth beyond 24 weeks.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Contacts

Public ContactM. Goddijn

Academic medical centre, location Q3-120 Postbus 22660

M.Goddijn@amc.uva.nl+31 (0)20 5663557

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)