Efficacy of Low Dose Levothyroxine During Pregnancy

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Euthyroid Females

Treatments: Drug: levothyroxin

Study type: Interventional

Funder types: Other

Identifiers

NCT03391154

asu maternity hosp

Details and patient eligibility

About

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

Full description

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

Enrollment: 180 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

levothyroxine

Active Comparator group

Description:

100 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

Treatment:

Drug: levothyroxin

control

No Intervention group

Description:

100 pregnant female with TSH of\> 2.5 mU/L but less than 4 mU/L after biochemical diagnosis of pregnancy will not receive any drug throughout the pregnancy