Effect of HCQ Combined With LT4 on LBR in Euthyroid Women With URPL and TPO-Ab
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About this trial
The goal of this clinical trial is to learn if combined treatment of levothyroxine and hydroxychloroquine would improve the live birth of euthyroid women with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
Researchers will compare combined treatment of levothyroxine and hydroxychloroquine to a treatment of levothyroxine alone to see if combined treatment works to improve live birth of euthyroid participants with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
Participants will:
* Receive combined treatment of levothyroxine and hydroxychloroquine or treatment of levothyroxine alone every day at least 8 weeks before pregnancy, and continue their treatment till the end of pregnancy. * Visit the clinic 4 weeks and 8 weeks after their treatments, and every 12 weeks before they get pregnant for checkups and tests. During their pregnancy, they will visit the clinic before gestation of 12 weeks, and will be followed up with phone call in the second trimester and after parturition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with history of two or more pregnancy loss with the same male partner (including biochemical pregnancies).
Karyotype analyses show no pathological abnormalities in each individual of the recruited couple.
Women aged between 20 and 40 years old (including 20 and 40).
Lupus anticoagulant (LA), anticardiolipin antibody (ACA), and anti-beta2-glycoprotein I antibodies (anti-β2-GP1 Ab) tests are all negative.
Disqualifiers
Rheumatic diseases, such as systemic lupus erythematosus, undifferentiated connective tissue disease, etc.
Metabolic or endocrine diseases, such as diabetes.
Abnormal renal function: plasma creatinine level ≥130 μmol/L or abnormal liver function: alanine aminotransferase ≥80U/L or aspartate aminotransferase ≥80U/L.
Hypertension and malignant tumors.
Trial design
Design model
Parallel
Treatments tested in this trial
hydroxychloroquine and levothyroxine
DrugHydroxychloroquine sulfate tablets will be given at a total daily dose of 0.2g to 0.4g based on individual weight as described above. During the study, if TSH is higher than 4.0 mIU/L or exceeds the lower limit of the reference range of the center in the first trimester, or TSH level exceeds the normal range of the center during the second or the third trimester, subjects will be instructed to suspend the medication and visit the Department of Endocrinology.
Levothyroxine
DrugLevothyroxine sodium tablets (Euthyrox, 50 μg) will be given 12.5μg \~50 μg daily based on patients' TSH levels and weights as described above. During the study, if TSH is higher than 4.0 mIU/L or exceeds the lower limit of the reference range of the center in the first trimester, or TSH level exceeds the normal range of the center during the second or the third trimester, subjects will be instructed to suspend the medication and visit the Department of Endocrinology.
Treatment groups
796 Participants
are divided into 2 treatment groupsGroup A: hydroxychloroquine and levothyroxine groupExperimental treatment 1 intervention
Group B: levothyroxine groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Birth of a living child beyond 28 weeks
The primary outcome is the proportion of women with a live birth at or beyond 28 completed weeks. This proportion will be calculated with the denominator totalling all women randomised, and the numerator (i.e., treatment successes) totalling women who conceive within 60 weeks of randomisation and go on to give live birth at or beyond 28 weeks gestation.
Time frame
After birth, within 24 months after randomizationSecondary outcomes
1
Clinical pregnancy at 5 to 8 weeks
It is the proportion of women with a cardiac activity confirmed by ultrasound during 5 to 8 weeks of gestation. This proportion will be calculated with the denominator totalling all women randomised, and the numerator totalling women who have clinical pregnancy within 60 weeks of randomisation.
Time frame
At 5-8 weeks of pregnancy2
Miscarriage <28 weeks
Miscarriage that occurs less than 28 weeks of gestation
Time frame
At 28 weeks of pregnancy3
Gestation at miscarriage, weeks
Gestation at miscarriage, weeks
Time frame
After the time of miscarriage, within 24 months after eligibility4
On-going pregnancy at 12 weeks
On-going pregnancy at 12 weeks
Time frame
At 12 weeks of pregnancySponsors and contacts
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Source ClinicalTrials.gov