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| ID | Type | Description | Link |
|---|---|---|---|
| 2021CR29 | Other Grant/Funding Number | Peking university first hospital |
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| Name | Class |
|---|---|
| National Research Institute for Family Planning, China | OTHER_GOV |
| The Fourth Hospital of Shijiazhuang | OTHER |
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The goal of this clinical trial is to learn if levothyroxine (L-T4) works to treat pregnant women with TSH 2.5 mIU/L-the upper limit of reference range (ULRR) of pregnancy and TPOAb-negative. It will also learn about the safety of L-T4. The main quesitons the investigator want to answer are:
Participants should:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an oral placebo group during pregnancy. Participants in our study will determine the dosage of medication based on their weight. |
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| Levothyroxine | Active Comparator | The target participants are women who undergo thyroid function and TPOAb testing in early pregnancy. Among these pregnant women, TSH 2.5mIU/L-ULRR and TPOAb negative pregnant women will be selected. Then, participants were randomly assigned 1:1 (based on age and BMI) to an active comparator group of oral Levothyroxine (L-T4) during pregnancy. Participants in our study will determine the dosage of medication based on their weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine Sodium (LT4) Tablets | Drug | Participants in our study will determine the dosage of L-T4 based on their weight (BW):
At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH:
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of fetal loss |
| From enrollment to the end of treatment at 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal loss rates and reasons within 12 weeks of pregnancy. | From enrollment to the end of treatment at 12 weeks | |
| Fetal loss rates and reasons within 24 weeks of pregnancy. | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Any unexpected medical occurrence in a subjects administered a pharmaceutical product and which may have no causal relationship with the treatment. An AE can be the aggravation of original symptoms, signs, laboratory abnormalities or newly diagnosed diseases, unfavorable and unintended symptoms, signs, clinically significant laboratory abnormalities, etc. The following situations should not be recorded as AEs:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Zhang, Doctor | Contact | 008601083575103 | emilyzy14@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, Professor | Endocrinology Department of Peking University First Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth hospital of Shijiazhuang city | Shijiazhuang | Heibei | 050011 | China |
the clinical information of the participants and the primary outcome data of the LIGHT study will be shared
IPD will be available half year after the last participants finished the study
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|
| Placebo | Drug | Participants in our study will determine the dosage of placebo based on their weight (BW):
At 12 weeks, 18-20 weeks, 24-26 weeks, and 34-36 weeks of gestation, the serum TSH, FT3, and FT4 will be measured, and investigator will adjust dosage according to TSH:
|
|
| Fetal loss rates and reasons within 28 weeks of pregnancy. | From enrollment to the end of treatment at 28 weeks |
| Fetal loss rates and reasons within 34 weeks of pregnancy. | From enrollment to the end of treatment at 34 weeks |
| Rate of cesarean section | From enrollment to the end of treatment at 40 weeks |
| Gestational week of delivery | From enrollment to the end of treatment at 40 weeks |
| Number of Participants requiring treatments for preventing miscarriage | Drugs, cervical cerclage, etc. | From enrollment to the end of treatment at 40 weeks |
| Rate of hyperemesis gravidarum | From enrollment to the end of treatment at 40 weeks |
| Rate of gestational diabetes | GDM:
| From enrollment to the end of treatment at 40 weeks |
| Rate of hypertensive disorders of pregnancy | Hypertensive disorders of pregnancy include: hypertension during pregnancy, preeclampsia and eclampsia | From enrollment to the end of treatment at 40 weeks |
| Rate of early preterm delivery | 28 weeks ≤ gestational week of delivery <34 weeks; | From enrollment to the end of treatment at 34 weeks |
| Rate of late preterm delivery | 34 weeks ≤ delivery gestational week <37 weeks | From enrollment to the end of treatment at 37 weeks |
| Rate of intrauterine growth restriction | From enrollment to the end of treatment at 40 weeks |
| Rate of abruption of placenta | From enrollment to the end of treatment at 40 weeks |
| Rate of dystocia | Dystocia: fetus delivery is difficult, requiring assisted delivery or cesarean section | From enrollment to the end of treatment at 40 weeks |
| Rate of macrosomia | Macrosomia: the newborn's birth weight >=4000 g | From enrollment to the end of newborn delivery date. |
| Rate of low birth weight | Low birth weight: the newborn's birth weight <2500 g | From enrollment to the end of newborn delivery date. |
| Incidence of composite adverse outcomes | The occurrence of one or more of these above events (maternal and fetal) was defined as the occurrence of prenatal composite adverse outcomes. | From enrollment to the end of treatment at 40 weeks |
| From enrollment to the end of treatment at 40 weeks |
| Serious adverse events (SAEs) | Defined as any untoward medical position that meets one or more of the following criteria:
| From enrollment to the end of treatment at 40 weeks |
| Thyrotoxicosis | Defined as serum TSH less than the lower limit of the pregnancy-specific reference range (or 0.1 mU/L). | From enrollment to the end of treatment at 40 weeks |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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