NCT04565873

Brief Summary

Retrospective comparative study comparing group 1 (TSH level 0.1-1.99 mIU/L) and group 2 (TSH level 2.0-4 mIU/L). Each group was further subdivided into primigravidae and multipara. 1527 pregnant women were included.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,527

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

September 9, 2020

Last Update Submit

September 24, 2020

Conditions

Pregnancy EarlyPregnancy RelatedThyroid Dysfunction

Keywords

TSHpregnancyFetal outcomematernal outcome

Outcome Measures

Primary Outcomes (1)

  • Feto-maternal outcome

    miscarriage rate, preterm delivery,

    4 years

Study Arms (4)

P1

Primigravida in group 1

Diagnostic Test: TSH

M1

Multipara in group 1

Diagnostic Test: TSH

P2

Primigravida in group 2

Diagnostic Test: TSH

M2

Multipara in group 2

Diagnostic Test: TSH

Interventions

TSHDIAGNOSTIC_TEST

retrospective TSH level

M1M2P1P2

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant patients
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant unknown to have thyroid disease

You may qualify if:

  • Pregnant women
  • Previously healthy

You may not qualify if:

  • \. known thyroid diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

Location

Study Officials

  • Al-Husban Naser

    The University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 25, 2020

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 25, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

retrospective; data are available on reasonable request

Locations

JO(1)