NCT03106935

Brief 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。

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

February 27, 2017

Last Update Submit

April 10, 2017

Conditions

Recurrent Pregnancy Loss

Keywords

recurrent pregnancy lossClinical hypothyroidismSubclinical hypothyroidismthyroid stimulating hormonethyroid peroxidase antibodyLevothyroxine

Outcome Measures

Primary Outcomes (3)

  • Gestational week at delivery

    The research doctor site telephoned every participant 2 weeks after the expected date of delivery to obtain pregnancy outcome data.

    28 weeks

  • Newborn birth weight

    The research doctor site telephoned every participant 2 weeks after the expected date of delivery to obtain newborn birth weight.

    at birth

  • APGAR Score at birth

    The APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting APGAR score ranges from zero to 10.

    at birth

Secondary Outcomes (3)

  • Number of clinical pregnancy at 6-8 weeks (defined as the presence of a gestational sac, with or without a yolk sac or fetal pole)

    8 weeks

  • Number of ongoing pregnancy at 12 weeks (defined as the presence of a fetal heartbeat)

    12weeks

  • Number of miscarriage (defined as loss of pregnancy before 28 weeks of gestation).

    28 weeks

Study Arms (2)

Obstet Gynecol,SecondSoochowU

ACTIVE COMPARATOR

Levothyroxine is an orodispersible tablet.For the LT4 treatment group, 50μg LT4 (Merck Serono, Geneva,Switzerland) was administered every morning from the first day of diagnosed as subclinical hypothyroidism and continued up to the day of serum β-HCG measurement.If pregnancy was confirmed, levothyroxine dose need to increase 25-30% and adjusted according to the pregnancy specific reference range ( T1 0.1-2.5mIU/L,T2 0.2-3.0mIU/L, T3 0.3-3.0mIU/L) .

Drug: Levothyroxine

reproductive center,SecondSoochowU

NO INTERVENTION

For the control group ,women with subclinical hypothyroidism are not given any drugs .

Interventions

LevothyroxineDRUG

Levothyroxine is an orodispersible tablet.For the LT4 treatment group, 50μg LT4 (Merck Serono, Geneva,Switzerland) was administered every morning from the first day of diagnosed as subclinical hypothyroidism and continued up to the day of serum β-HCG measurement.If pregnancy was confirmed, levothyroxine dose need to increase 25-30% and adjusted according to the pregnancy specific reference range ( T1 0.1-2.5mIU/L,T2 0.2-3.0mIU/L, T3 0.3-3.0mIU/L) .

Also known as: LT4
Obstet Gynecol,SecondSoochowU

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • they had any contraindications to Levothyroxine use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Related Publications (4)

  • Zhu LY, Chen X, Xu ZZ, Xu L, Mao T, Zhang H. Changes and clinical significance of peripheral blood helper T lymphocyte and natural killer (NK) cells in unexplained recurrent spontaneous abortion (URSA) patients after abortion and successful pregnancy. Clin Exp Obstet Gynecol. 2015;42(1):62-6.

    PMID: 25864284BACKGROUND

  • Wu S, Zhang H, Tian J, Liu L, Dong Y, Mao T. Expression of kisspeptin/GPR54 and PIBF/PR in the first trimester trophoblast and decidua of women with recurrent spontaneous abortion. Pathol Res Pract. 2014 Jan;210(1):47-54. doi: 10.1016/j.prp.2013.09.017. Epub 2013 Oct 26.

    PMID: 24225150BACKGROUND

  • Zhang H, Long Q, Ling L, Gao A, Li H, Lin Q. Elevated expression of KiSS-1 in placenta of preeclampsia and its effect on trophoblast. Reprod Biol. 2011 Jul;11(2):99-115. doi: 10.1016/s1642-431x(12)60048-5.

    PMID: 21804632BACKGROUND

  • Mao C, Zhang H, Xiao D, Zhu L, Ding Y, Zhang Y, Wu L, Xu Z, Zhang L. Perinatal nicotine exposure alters AT 1 and AT 2 receptor expression pattern in the brain of fetal and offspring rats. Brain Res. 2008 Dec 3;1243:47-52. doi: 10.1016/j.brainres.2008.09.060. Epub 2008 Oct 2.

    PMID: 18926802BACKGROUND

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • ZHANG Hong, Ph.D,M.D

    a staff of The Second Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D,M.D

Study Record Dates

First Submitted

February 27, 2017

First Posted

April 11, 2017

Study Start

July 1, 2015

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

CN(1)