Recurrent Pregnancy Loss and Thyroid Disease (NCT03106935) | Clinical Trial Compass
UnknownEarly Phase 1
Recurrent Pregnancy Loss and Thyroid Disease
China300 participantsStarted 2015-07
Plain-language summary
The present study is divided into two groups ,one is the patients with subclinical hypothyroidism who has TPO antibody positive women with TSH concentrations \> 2.5 mU/L and below the upper limit of the pregnancy specific reference range ,another is TPO antibody negative with TSH concentrations greater than the pregnancy specific reference range and below 10.0 mU/L.The two groups are randomized into either the LT4 treatment group or control group by the use of a computer-generated list.
The aim of our study is to determine whether the use of levothyroxine is beneficial in patients with subclinical hypothyroidism in two groups。
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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Inclusion criteria
✓. having a diagnosis of RPL (two or more consecutive or non-consecutive first-trimester losses)
✓. be.ing aged 18-39 years at randomisation
✓. trying to conceive naturally
✓. willing and able to give informed consent
Exclusion criteria
✕. they were unable to conceive naturally (as confirmed by urinary pregnancy tests) within 1 year of recruitment or before the end of the randomisation period in the trial, whichever came earlier
✕. they had antiphospholipid syndrome \[lupus anticoagulant and/or anticardiolipin antibodies (immunoglobulin G or immunoglobulin M)\]; other recognised thrombophilic conditions (testing according to usual clinic practice) l they had uterine cavity abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram or hysteroscopy)
✕. they had abnormal parental karyotype
✕. they had other identifiable causes of RPL (tests initiated only if clinically indicated) such as diabetes or systemic lupus erythematosus
What they're measuring
1
Gestational week at delivery
Timeframe: 28 weeks
2
Newborn birth weight
Timeframe: at birth
3
APGAR Score at birth
Timeframe: at birth
Trial details
NCT IDNCT03106935
SponsorSecond Affiliated Hospital of Soochow University