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Efficacy of Low Dose Levothyroxine During Pregnancy

Phase 3
Completed
Conditions
Euthyroid Females
Interventions
Registration Number
NCT03391154
Lead Sponsor
Ain Shams University
Brief Summary

the effect using low dose levo thyroxine in pregnant females with TSH level more than 2.5 mU/L in the first trimester on pregnancy outcome

Detailed Description

the study aim to detect the effect of low dose levothyroxine 50 ug on pregnant females and compare it with others receiving placebo

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
180
Inclusion Criteria
  • females with TSH more than 2.5 mU/L and less than 4 mU/L after biochemical diagnosis of pregnancy.
Exclusion Criteria
  • associated endocrinopathies (PCO/ DM/ hyperprolactinemia )
  • associated medical condition (HTN/ chronic kidney disease.
  • history of recurrent pregnancy loss

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
levothyroxinelevothyroxin100 pregnant female with TSH of\> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will receive 50 ug of levothyroxine (eltroxin 50) aspen,Egypt throughout the pregnancy
Primary Outcome Measures
NameTimeMethod
1st trimester miscarriageduring 1st 13 weeks of pregnancy

1st trimester spontaneous or missed abortion

Secondary Outcome Measures
NameTimeMethod
adverse pregnancy outcomelast 26 week of gestation

2nd trimesteric missed or spontaneous abortion ,gestational hypertension,preeclampsia, anemia, abruptio placenta premature delivery , fetal growth restriction, low birth weight

Trial Locations

Locations (1)

AinShams university maternity hospital

🇪🇬

Cairo, Abbassya, Egypt

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