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OpenTrials
Completed

NCT Number: NCT03391154

Efficacy of Low Dose Levothyroxine During Pregnancy

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

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

AinShams university maternity hospital

Cairo, Abbassya, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levothyroxin

Drug

90 female received levothroxine

Primary outcomes

  1. 1st trimester miscarriage

    Time frame: during 1st 13 weeks of pregnancy

    1st trimester spontaneous or missed abortion

Secondary outcomes

  1. adverse pregnancy outcome

    Time frame: last 26 week of gestation

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2018
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.