Efficacy of Low Dose Levothyroxine During Pregnancy

NCT ID: NCT03391154

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Euthyroid Females

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

levothyroxine

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

Group Type ACTIVE_COMPARATOR

levothyroxin

Intervention Type DRUG

90 female received levothroxine

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

levothyroxin

90 female received levothroxine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Radwa Rasheedy Ali

lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AinShams university maternity hospital

Cairo, Abbassya, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

asu maternity hosp

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Recurrent Pregnancy Loss and Thyroid Disease
NCT03106935 UNKNOWN EARLY_PHASE1