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Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy

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ClinicalTrials.gov Identifier: NCT04565873
Recruitment Status : Completed
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Naser Al-Husban, University of Jordan

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.

Condition or disease Intervention/treatment
Pregnancy Early Pregnancy Related Thyroid Dysfunction Diagnostic Test: TSH

Detailed Description:

This was a retrospective comparative study spanning January 2014 to December 2018. It was conducted at Jordan university hospital, a teaching referral hospital affiliated to the University of Jordan, Amman, Jordan. Pregnant patients, both primigravida and multipara who had a spontaneous singleton pregnancy with documented TSH level in the first 16 weeks' gestation were included. The investigators excluded all patients who had known thyroid dysfunction whether on treatment or not, molar pregnancies, multiple pregnancies, patients with hyperemesis gravidarum, all patients with anti-thyroid antibodies (Anti-TPO), patients with TSH ˃ 4.0 mIU/L or ˂ 0.1 mIU/L. This range was used as TSH ˂ 0.1 mIU/L indicated an undiagnosed subclinical hyperthyroidism and TSH ˃4.0 indicated undiagnosed hypothyroidism. In addition, there were wide variations in the TSH reference ranges. Participants' data were collected retrospectively from antenatal clinic notes, admission notes, labor ward and operative notes. Data included patients ID number, age, parity, body mass index (BMI) in kg/m2, TSH values in the first 16 weeks of pregnancy. The participants were divided into 2 groups according to their TSH values. Group one with TSH values between 0.1-1.99 mIU/L. Group 2 had TSH values between 2-4 mIU/L. Each group was then subdivided into 2 subgroups; primigravida and multipara. Group P1: Primigravida in group 1, Group P2: Primigravida in group 2, Group M1: Multiparous in group 1, Group M2: Multiparous in group 2.

The investigators calculated the mean, median and range of TSH in each subgroup. The feto-maternal outcome was then compared between the 2 groups. The investigators studied miscarriage rate, ectopic pregnancy rate, maternal blood sugar values (Fasting blood sugar (FBS), glucose tolerance test (GTT), HbA1c or a combination) between 26 and 34 weeks, development of high blood pressure at delivery, duration of pregnancy (gestational age at delivery), preterm delivery rate, abruption placenta, mode of delivery, birth weight and APGAR score at 1 and 5 minutes. Gestational diabetes mellitus (GDM) was diagnosed as an FBS 92-125 mg/dL or 1-hour plasma glucose levels of 180 or more following 75-gram oral glucose load or 2-hour plasma glucose 153-199 mg/dL. The study obtained the approval of the institutional review board (IRB) at Jordan University Hospital (JUH) number 179/2019 dated 17/4/2019.

The statistical analysis was performed with the Data Toolkit in Excel (Microsoft, Redmond, WA, USA) using descriptive analysis. Relative risk and 95% confidence intervals were also calculated to compare variables. P values were considered significant at ˂0.05. The obtained data were examined using a frequency table and are presented as frequency, percentage and mean

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Study Type : Observational
Actual Enrollment : 1527 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy and Feto-maternal Outcome; Retrospective Study.
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
P1
Primigravida in group 1
Diagnostic Test: TSH
retrospective TSH level

M1
Multipara in group 1
Diagnostic Test: TSH
retrospective TSH level

P2
Primigravida in group 2
Diagnostic Test: TSH
retrospective TSH level

M2
Multipara in group 2
Diagnostic Test: TSH
retrospective TSH level




Primary Outcome Measures :
  1. Feto-maternal outcome [ Time Frame: 4 years ]
    miscarriage rate, preterm delivery,



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant patients
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant unknown to have thyroid disease
Criteria

Inclusion Criteria:

  1. Pregnant women
  2. Previously healthy

Exclusion Criteria:

1. known thyroid diseases


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565873


Locations
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Jordan
The University of Jordan
Amman, Jordan, 11942
Sponsors and Collaborators
University of Jordan
Investigators
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Principal Investigator: Al-Husban Naser the University Of Jordan
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Responsible Party: Naser Al-Husban, Assistant Professor, University of Jordan
ClinicalTrials.gov Identifier: NCT04565873    
Other Study ID Numbers: retrospective study
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: retrospective; data are available on reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naser Al-Husban, University of Jordan:
TSH
pregnancy
Fetal outcome
maternal outcome
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases