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Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy

U

University of Jordan

Status

Completed

Conditions

Thyroid Dysfunction
Pregnancy Related
Pregnancy Early

Treatments

Diagnostic Test: TSH

Study type

Observational

Funder types

Other

Identifiers

NCT04565873
retrospective study

Details and patient eligibility

About

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.

Full 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

Enrollment

1,527 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Pregnant women
  2. Previously healthy

Exclusion criteria

  1. known thyroid diseases

Trial design

1,527 participants in 4 patient groups

P1
Description:
Primigravida in group 1
Treatment:
Diagnostic Test: TSH
M1
Description:
Multipara in group 1
Treatment:
Diagnostic Test: TSH
P2
Description:
Primigravida in group 2
Treatment:
Diagnostic Test: TSH
M2
Description:
Multipara in group 2
Treatment:
Diagnostic Test: TSH

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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