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Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in pregnant women with isolated hypothyroxinemia

Protocol summary

Summary
This study will be conducted to determine the effectiveness of the effect of Levothyroxine on pregnancy outcome of pregnant women with isolated hypothyroxinemia of two parts: in the first stage thyroid hormones are tested in 1600 pregnant women in the first 20 weeks of pregnancy and pregnant women with in pregnant women with isolated hypothyroxinemia are identified. Three times urine during a week are also sampled for iodine measurement. Women with normal TSH less than 2.5 mIU/ liter) and FTI less than 1 in the first 20 weeks of pregnancy, will enter into the second phase of the study. In the second stage of study, pregnant women with in pregnant women with isolated hypothyroxinemia are divided simple randomly (based on the odd or even sample code) into two groups. The first group, intervention group, is treated with levothyroxine. The second group, control group, received placebo. In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery and abnormal cases are recorded. In the second and third trimester, women’s serum samples are evaluated for TSH, T4 and T3uptake and newborns’ serum samples are collected for TSH analysis. The intervention groups is compared with control group according to pregnancy outcome including: abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membrane, third trimester hemorrhage and newborns’ thyroid hormone levels at birth.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121714849N4
Registration date: 2014-01-06, 1392/10/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-06, 1392/10/16
Registrant information
Name
Sima Nazarpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 0340
Email address
simanazarpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in pregnant women with isolated hypothyroxinemia
Public title
The effect of intervention by Levothyroxine on pregnancy outcome of pregnant women with isolated hypothyroxinemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women during the first 20 weeks of pregnancy.should not have contraindications for taking levothyroxine contraindication of Levothyroxine include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension.
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this clinical trial no subject knows whether she is receiving particular treatments (levothyroxine) or lack of treatment (placebo), but the administrator does have that information.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences, Research Institute for Endocrin
Street address
Velenjak St., Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-10-15, 1392/07/23
Ethics committee reference number
33ECRIES92/07/23

Health conditions studied

1

Description of health condition studied
Preterm labor
ICD-10 code
O60
ICD-10 code description
Preterm labour and delivery

2

Description of health condition studied
Abortion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion

3

Description of health condition studied
Low birth weight
ICD-10 code
P07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified

4

Description of health condition studied
Intra uterine growth restriction
ICD-10 code
P05
ICD-10 code description
Slow fetal growth and fetal malnutrition

5

Description of health condition studied
Premature rupture of membranes
ICD-10 code
O42
ICD-10 code description
Premature rupture of membranes

6

Description of health condition studied
Third trimester hemorrhage
ICD-10 code
O44 , O45
ICD-10 code description
Placenta previa, Premature separation of placenta [abruptio placentae]

Primary outcomes

1

Description
Abortion
Timepoint
Up to 20 weeks of pregnancy (In cases that intervention begins in first trimester)
Method of measurement
Checklist

2

Description
Preterm labor
Timepoint
20 to 37 weeks of pregnancy (within 1 to 6 months after intervention)
Method of measurement
Checklist

3

Description
Low birth weight
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist

4

Description
Intra uterine growth restriction
Timepoint
5 to 7 months after intervention
Method of measurement
Checklist

5

Description
Premature rupture of membranes (PROM)
Timepoint
5 to 7 months after intervention
Method of measurement
Checklist

6

Description
Third trimester hemorrhage
Timepoint
Third trimester (2 to 5 months after intervention)
Method of measurement
Checklist

7

Description
TSH level of newborn at birth (day 3 to5 births)
Timepoint
3 to 5 days after birth (5 to 7 months after intervention)
Method of measurement
Immunoradiometric assay (IRMA)

Secondary outcomes

1

Description
Thyroid hormones (T4, T3 uptake, TSH) in second and third trimester
Timepoint
20th and 30th week of pregnancy
Method of measurement
T4: Radioimmuno assay (RIA), TSH: Immunoradiometric assay (IRMA), T3uptake: ELISA

2

Description
Blood pressure
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor
Method of measurement
Blood pressure measuring devices

3

Description
Edema
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation)
Method of measurement
Checklist

4

Description
Fetal heart rate (FHR)
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor
Method of measurement
Pinard Stethoscope

5

Description
Headache
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation)
Method of measurement
Checklist

6

Description
Vaginal bleeding
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor
Method of measurement
Checklist

7

Description
Uterine contractions
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation)
Method of measurement
Checklist

8

Description
Type of delivery
Timepoint
Delivery (5 to 7 months after intervention)
Method of measurement
Checklist

9

Description
Postpartum atonia
Timepoint
Postpartum (5 to 7 months after intervention)
Method of measurement
Checklist

10

Description
Postpartum hemorrhage
Timepoint
Postpartum (5 to 7 months after intervention)
Method of measurement
Checklist

11

Description
Newborn Apgar
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Apgar Apgar scoring

12

Description
Hospitalization in neonatal intensive care unit (NICU)
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist

13

Description
Newborn convulsion
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist

14

Description
Newborn icterus
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist

Intervention groups

1

Description
Intervention group will treat with LT4: these patients will receive a dose of 0.5 microgram/kg.d if they have TSH less than 1.0 mIU/liter, 0.75 microgram/kg.d for TSH between 1.0 and 2.0 mIU/liter, and 1 microgram/kg.d for TSH higher than 2.0 mIU/liter. Dosages will maintain throughout gestation.
Category
Treatment - Drugs

2

Description
Will take placebo.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Varamin, Pishva and Qarchak
Full name of responsible person
Sima Nazarpour
Street address
Varamin, Pishva , Qarchak
City
Varamin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi (Vice chancellor for research, Shahid Beheshti University of Medical Sciences)
Street address
Velenjak Street , Shahid Chamran Highway, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Midwifery and Nursing department
Full name of responsible person
Sima Nazarpour
Position
PhD student in the field of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8865 5366
Fax
Email
simanazarpour@sbmu.ac.ir; nazarpoursima@yahoo
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
Gynecologist
Other areas of specialty/work
Street address
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2243 2500
Fax
Email
fah.tehrani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Nursing and Midwifery department
Full name of responsible person
Sima Nazarpour
Position
PhD student in the field of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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