Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565873
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-09-09
Brief Title:
Thyroid Stimulating Hormone TSH Level Variations in Early Pregnancy
Sponsor:
University of Jordan
Organization:
University of Jordan
Study Overview
Official Title:
Thyroid Stimulating Hormone TSH Level Variations in Early Pregnancy and Feto-maternal Outcome Retrospective Study
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retrospective comparative study comparing group 1 TSH level 01-199 mIUL and group 2 TSH level 20-4 mIUL Each group was further subdivided into primigravidae and multipara 1527 pregnant women were included
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 40 mIUL or 01 mIUL This range was used as TSH 01 mIUL indicated an undiagnosed subclinical hyperthyroidism and TSH 40 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 kgm2 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 01-199 mIUL Group 2 had TSH values between 2-4 mIUL 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 mgdL or 1-hour plasma glucose levels of 180 or more following 75-gram oral glucose load or 2-hour plasma glucose 153-199 mgdL The study obtained the approval of the institutional review board IRB at Jordan University Hospital JUH number 1792019 dated 1742019
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 005 The obtained data were examined using a frequency table and are presented as frequency percentage and mean
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 mgdL or 1-hour plasma glucose levels of 180 or more following 75-gram oral glucose load or 2-hour plasma glucose 153-199 mgdL The study obtained the approval of the institutional review board IRB at Jordan University Hospital JUH number 1792019 dated 1742019
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 005 The obtained data were examined using a frequency table and are presented as frequency percentage and mean
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None