URPL 및 TPO-Ab가 있는 정상 갑상선 여성의 LBR에 대한 LT4와 결합된 HCQ의 효과 (QT-LIFE)
갑상선 항체 양성 및 설명할 수 없는 재발성 임신 손실을 보이는 갑상선 기능 정상 여성에서 레보티록신과 결합된 하이드록시클로로퀸의 효능: 다기관, 무작위 대조 연구
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.
연구 개요
상태
상세 설명
Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent pregnancy loss. According to 2017 Guidelines of the American Thyroid Association, administration of levothyroxine (LT4) to TPO-Ab-positive euthyroid pregnant women with a prior history of loss may be considered given its potential benefits in comparison with its minimal risk. However, it is a weak recommendation with low-quality evidence. Recently published randomised clinical trials showed that administration of LT4 does not improve pregnancy outcomes of euthyroid thyroid peroxidase antibody positive women with recurrent pregnancy loss. Published data showed TPO-Ab is related to immune imbalance. Hydroxychloroquine is a widely used immune modulator even in fields of autoimmune disorders during pregnancy and lactation. Nevertheless, the effect of hydroxychloroquine combined with LT4 on live birth rate of euthyroid women with TPO-Ab and unexplained recurrent pregnancy loss is unclear. Therefore, we designed a multicenter RCT to verify the study hypothesis that combined treatment of levothyroxine and hydroxychloroquine would improve the live birth rate of euthyroid women with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510120
- 아직 모집하지 않음
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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연락하다:
- Hui Chen, M.D.
- 이메일: chenhui9@mail.sysu.edu.cn
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연락하다:
- Zhuoyao Mai, M.D.
- 이메일: maizhy5@mail.sysu.edu.cn
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Guangzhou, Guangdong, 중국, 510000
- 모병
- Sun Yat-Sen Memorial Hospital
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연락하다:
- Zhuoyao Mai, doctor
- 전화번호: 020-81332233
- 이메일: maizhuoyaoemma@126.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- 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.
- It is confirmed by ultrasound or hysteroscopy that there are no pathological lesions that affect the morphology of the uterine cavity (such as submucosal uterine fibroids, uterine malformations).
- TPO-Ab positive (TPO-Ab > 60 IU/mL using the Siemens kit of electrochemiluminescence method, or TPO-Ab > 34 IU/mL using the Roche kit of chemiluminescence method or other testing methods).
- Biochemically euthyroid. TSH, free triiodothyronine (FT3), and free thyroxine (T4) are all within the reference range of corresponding laboratory testing in each research center.
Exclusion criteria:
- 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.
- Under treatment with glucocorticoids or immunosuppressor, including cyclosporine, azathioprine, prednisone, and methylprednisolone.
- Body Mass Index (BMI) >28kg/m2.
- Past history of hyperthyroidism, hypothyroidism, and thyroid malignant tumors;
- Allergy to 4-aminoquinoline compound, or those with retinal or visual field lesions caused by 4-aminoquinoline compound.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: hydroxychloroquine and levothyroxine group
Corresponding oral treatment will be initiated after randomization and preconceptually, and continue to the end of pregnancy or until 60 weeks post-randomisation if pregnancy does not occur. Patients in the experimental group will be given a combined oral treatment of hydroxychloroquine (HCQ) and levothyroxine. Hydroxychloroquine sulfate tablets will be given at a total daily dose of 0.2g to 0.4g based on individual weight: patients weighing ≤46kg take HCQ tablets 0.2g/d, patients weighing >46kg and <62kg take HCQ tablets 0.3g/d, patients weighing ≥62kg take HCQ tablets 0.4g/d. Levothyroxine sodium tablets (Euthyrox, 50 μg) will be given 12.5μg ~50 μg daily based on patients' TSH levels and weights: TSH ≥ 2.5 mIU/L, the dosage is 50 μg/d; TSH < 2.5 mIU/L, the dosage is 25 μg/d; when the patient's weight is less than 50kg, the dosage is reduced by 50%. |
Hydroxychloroquine 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. |
|
다른: levothyroxine group
Corresponding oral treatment will be initiated after randomization and preconceptually, and continued to the end of any pregnancy or until 60 weeks post-randomisation if pregnancy does not occur. Patients assigned in the control group will be given levothyroxine daily. Levothyroxine sodium tablets will be given 12.5μg ~50 μg daily based on patients' TSH levels and weights: TSH ≥ 2.5 mIU/L, the dosage is 50 μg/d; TSH < 2.5 mIU/L, the dosage is 25 μg/d; when the patient's weight is less than 50kg, the dosage is reduced by 50%. |
Levothyroxine 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Birth of a living child beyond 28 weeks
기간: After birth, within 24 months after randomization
|
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. |
After birth, within 24 months after randomization
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical pregnancy at 5 to 8 weeks
기간: At 5-8 weeks of pregnancy
|
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. |
At 5-8 weeks of pregnancy
|
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Miscarriage <28 weeks
기간: At 28 weeks of pregnancy
|
Miscarriage that occurs less than 28 weeks of gestation |
At 28 weeks of pregnancy
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Gestation at miscarriage, weeks
기간: After the time of miscarriage, within 24 months after eligibility
|
Gestation at miscarriage, weeks |
After the time of miscarriage, within 24 months after eligibility
|
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On-going pregnancy at 12 weeks
기간: At 12 weeks of pregnancy
|
On-going pregnancy at 12 weeks |
At 12 weeks of pregnancy
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Gestation at delivery >34 weeks/>37 weeks
기간: After birth, within 24 months after eligibility
|
Number of women who have a delivery at least 34 weeks of gestation. Number of women who have a delivery at least 37 weeks of gestation. |
After birth, within 24 months after eligibility
|
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Gestation at delivery, weeks
기간: After birth, within 24 months after eligibility
|
Gestation at delivery, weeks |
After birth, within 24 months after eligibility
|
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Birth weight, grams
기간: At birth, within 24 months after eligibility
|
Birth weight, grams |
At birth, within 24 months after eligibility
|
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APGAR score at 1 minute/5 minutes
기간: After birth, within 24 months after eligibility
|
APGAR score at 1 minute/5 minutes of the neonates. |
After birth, within 24 months after eligibility
|
|
birth defects
기간: At or short after birth, within 24 months after eligibility
|
Birth defects of the neonates. |
At or short after birth, within 24 months after eligibility
|
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Maternal antenatal complications,intrapartum complications,maternal postnatal complications
기간: up to birth/immediately after delivery
|
Hypertensive disorders of pregnancy, gestational diabetes, placenta previa, placental abruption, polyhydramnios, oligohydramnios, fetal growth restriction, postpartum hemorrhage and so on. |
up to birth/immediately after delivery
|
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Time to pregnancy.
기간: At 5-8 weeks of pregnancy
|
It refers to the time interval from patients trying to prepare for pregnancy (after 8 weeks of medication) to successful pregnancy (intrauterine pregnancy confirmed by ultrasound). |
At 5-8 weeks of pregnancy
|
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live birth rate after at least 28 weeks of gestation among pregnant patients
기간: After birth, within 24 months after randomization
|
It is the proportion of women with a live birth at or beyond 28 of completed weeks. This proportion will be calculated with the denominator totalling all women who have clinical pregnancy within 60 weeks of randomisation, and the numerator totalling women who have a live birth at or beyond 28 of completed weeks. |
After birth, within 24 months after randomization
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SYSKY-2024-342-01
약물 및 장치 정보, 연구 문서
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