Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy

Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy and Feto-maternal Outcome; Retrospective Study.

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Thyroid Dysfunction; Pregnancy Early
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 1527

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • The university of Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant unknown to have thyroid disease

Description

Inclusion Criteria:

1. Pregnant women
2. Previously healthy

Exclusion Criteria:

1. known thyroid diseases

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feto-maternal outcome	miscarriage rate, preterm delivery,	4 years

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Principal Investigator: Al-Husban Naser, The university of Jordan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (ACTUAL): September 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: pregnancy; TSH; maternal outcome; Fetal outcome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: Retrospective study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: retrospective; data are available on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No