NCT03391154

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

3.3 years

First QC Date

December 22, 2017

Last Update Submit

September 30, 2021

Conditions

Euthyroid Females

Outcome Measures

Primary Outcomes (1)

  • 1st trimester miscarriage

    1st trimester spontaneous or missed abortion

    during 1st 13 weeks of pregnancy

Secondary Outcomes (1)

  • adverse pregnancy outcome

    last 26 week of gestation

Study Arms (2)

levothyroxine

ACTIVE COMPARATOR

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

Drug: levothyroxin

control

NO INTERVENTION

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

Interventions

levothyroxinDRUG

90 female received levothroxine

levothyroxine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • females with TSH more than 2.5 mU/L and less than 4 mU/L after biochemical diagnosis of pregnancy.

You may not qualify if:

  • associated endocrinopathies (PCO/ DM/ hyperprolactinemia )
  • associated medical condition (HTN/ chronic kidney disease.
  • history of recurrent pregnancy loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, Egypt

Location

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 5, 2018

Study Start

May 1, 2017

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

October 7, 2021

Record last verified: 2021-09

Locations

EG(1)