Back to resultsThyroid Therapy for Mild Thyroid Deficiency in Pregnancy (TSH)
Primary Purpose
Subclinical Hypothyroidism, Hypothyroxinemia, Pregnancy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levothyroxine
Placebo for Levothyroxine
Sponsored by
About this trial
This is an interventional treatment trial for Subclinical Hypothyroidism focused on measuring Subclinical Hypothyroidism, Hypothyroxinemia, Thyroid, Pregnancy, Intellectual Development
Eligibility Criteria
Inclusion Criteria:
- Subclinical Hypothyroidism as defined by an elevated TSH (≥ 3.00 mU/L) and a free-T4 in the normal range (i.e. 0.86 to 1.90 ng/dL) or Hypothyroxinemia as defined by a TSH in the normal range (0.08 to 2.99 micrometers (mU)/L) and a low free-T4 (<0.86 ng/dL)
- Singleton Pregnancy
- Gestational age at randomization between 8 weeks 0 days and 20 weeks 6 days
Exclusion Criteria:
- Major fetal anomaly or demise
- Planned termination of the pregnancy
- History of thyroid cancer or current thyroid disease requiring medication
- Diabetes, on medication (insulin, glyburide)
- Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication
- Receiving anticoagulant therapy
- Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs)
Other known serious maternal medical complications including:
- Chronic hypertension requiring antihypertensive medication (including diuretics)
- Epilepsy or other seizure disorder, on medication
- Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes
- Cancer (including melanoma but excluding other skin cancers)
- Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion.
- Asthma, on oral corticosteroids
- Known illicit drug or alcohol abuse during current pregnancy
- Delivery at a non-network hospital
- Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
- Unwilling or unable to commit to 5 year follow-up of the infant
Sites / Locations
- University of Alabama - Birmingham
- Northwestern University
- Wayne State University
- Columbia University
- University of North Carolina - Chapel Hill
- Case Western University
- Ohio State University
- Oregon Health & Sciences University
- University of Pittsburgh Magee Womens Hospital
- Brown University
- University of Texas - Southwest
- University of Texas Medical Branch - Galveston
- University of Texas-Houston
- University of Utah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Levothyroxine for Subclinical Hypothyroidism
Placebo for Levothyroxine - Subclinincal Hypothyroidism
Levothyroxine for Hypothyroxinemia - Hypothyroxinemia
Placebo for Levothyroxine
Arm Description
100 µg of Levothryoxine for participants with subclinical hypothyroidism
Placebo for Levothyroxine for participants with subclinical hypothyroidism
50 µg of Levothyroxine for participants with hypothyroxinemia
Placebo for Levothyroxine for participants with hypothyroxinemia
Outcomes
Primary Outcome Measures
Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death.
The primary outcome was death or IQ score at 5 years of age (or at 3 years of age if the 5-year examination was missing). The full-scale IQ was assessed with the use of the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age or the overall (general conceptual ability) score from the Differential Ability Scales-II at 3 years of age if the WPPSI-III score was not available. Results are expressed as an age-standardized score, with an expected population mean of 100 and a standard deviation of 15. Death before 3 years of age was assigned a score of 0 (lowest possible rank) and was included in the estimation of the median.
For Quotient and Composite score:
below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+
Secondary Outcome Measures
Week of Gestation at Delivery
Gestational age at delivery and preterm birth < 37 weeks' gestation or < 34 weeks' gestation
Number of Participants With Preterm Delivery
Preterm delivery at less than 37 weeks or less than 34 weeks gestation
Selected Cognitive Abilities From the Subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Standardized full-scale IQ scores from the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3.
For Quotient and Composite score:
below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.
Cognitive and Achievement Levels From the Differential Ability Scales (DAS II)
Overall general conceptual ability score as measured by the DAS-II at 36 months of age.
GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low
≤ 69 Very low
Cognitive and Achievement Levels From Two DAS-II Subtests (Recall of Digits Forward and Recognition of Pictures)
Cognitive and achievement levels from two DAS-II subtests (Recall of Digits Forward and Recognition of Pictures)
GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low
≤ 69 Very low
Cognitive, Motor and Language Scale Scores From the Bayley Certified Scales of Infant Development III Edition
Composite scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Results can also be expressed as percentile ranks relative to the standardization sample, with a mean and median of 50 and range from 1 to 99
Behavioral Problems and Social Competencies at 36 and 60 Months of Age, as Measured by the Child Behavior Checklist (CBCL)
Behavioral problems and social competencies at 36 and 60 months of age, as measured by the Child Behavior Checklist (CBCL). The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. A Tscore of less than 60 is considered to be in the normal range. A T score of 60-63 is a borderline, and a T score of more than 63 is in the clinical range. Lower scores represent better outcomes.
Attention Deficit Hyperactivity Disorder (ADHD) Index Score From the Connors' Rating Scales (Parent-S) - Revised
The Conners' Rating Scales-Revised were used to assess attention deficit-hyperactivity disorder (ADHD). A T score of 45 to 55 is considered to be typical or average; a T score of 44 or less is not a concern, a T score of 56 to 60 is considered to be a borderline score, and a T score of 61 or higher indicates a possible or clinically significant problem.
Participants With Placental Abruption
Clinically significant placental abruption will be determined by centralized (blinded) chart review
Participants With Gestational Hypertension
Gestational hypertension defined as patient having a diastolic ≥ 90 during pregnancy without proteinuria
Participants With Preeclampsia
Preeclampsia defined as patient having a diastolic ≥ 90 during pregnancy with at least 1 + proteinuria. Preeclampsia will also include HELLP syndrome or eclampsia.
Gestational Diabetes Mellitus
A patient is considered to have gestational diabetes if clinically diagnosed with class A1 or A2
Participants With Composite Neonatal Outcome
The composite neonatal outcome was defined as periventricular leukomalacia, intraventricular hemorrhage of grade III or IV, necrotizing enterocolitis (stage ≥II), severe retinopathy of prematurity (stage ≥III), the severe respiratory distress syndrome, bronchopulmonary dysplasia, neonatal death, stillbirth, or serious infectious complication.
Participants Who Experienced a Stillbirth or Miscarriage
Stillbirth or miscarriage.
Number of Neonatal Deaths
Fetal and neonatal death
Number of Infants With Apgar Score 4 at 1 Minute and < 7 at 5 Minutes
Apgar score < 4 at 1 minute and < 7 at 5 minutes
Number of Infants Admitted to NICU
Admission to NICU
Infants With Birth Weight < 10th Percentile (Gestational Age z Score)
Birth weight < 10th percentile (gestational age z score)
Neonatal Head Circumference (Centimeters)
Neonatal head circumference measured within 24 hours of birth. This measurement is included based on a report showing that maternal treatment with thyroxine for overt hypothyroidism was associated with reduced head circumference in the newborn infant
Number of Infants With Respiratory Distress Syndrome
Respiratory distress syndrome (RDS) will be defined based on a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 ≥ 0.40) for greater than or equal to 24 hours. For infants dying before 24 hours of age, a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 ≥ 0.40) are sufficient.
Number of Infants With Retinopathy or Prematurity
This diagnosis will be reached when an ophthalmologic examination of the retina has been performed and ROP is diagnosed at Stage I (demarcation line in the retina) or greater
Number of Infants With Necrotizing Enterocolitis
Necrotizing enterocolitis (NEC) is defined by the following: the unequivocal presence of intramural air on abdominal x-ray, perforation seen on abdominal x-ray, clinical evidence as suggested by erythema and induration of the abdominal wall, or intra-abdominal abscess formation, or stricture formation observed at surgery or autopsy following an episode of suspected NEC. The condition is classified based on the Bell staging system
Number of Infants With Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is defined as the need for supplemental oxygen at 36 weeks corrected age, for babies born <34 weeks by project gestational age only
Number of Infants With Respiratory Therapy Greater Than or Equal to 1 Day
oxygen therapy (FiO2 ≥ 0.40) for greater than or equal to 24 hours
Number of Days in the Hospital Nursery
Median number of days in the hospital nursery
Full Information
NCT ID
NCT00388297
First Posted
October 12, 2006
Last Updated
February 19, 2019
Sponsor
The George Washington University Biostatistics Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00388297
Brief Title
Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
Acronym
TSH
Official Title
A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Washington University Biostatistics Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether treating women, who are diagnosed with a mild imbalance of thyroid hormones during pregnancy, with thyroid hormone replacement affects their children's intellectual development at 5 years of age.
Detailed Description
Published research reports have stimulated national and international controversy regarding the value of maternal thyroxine therapy given to improve neurodevelopment of the fetus in women with variously defined hypothyroidism. These reports have led to conflicting and confusing recommendations as to whether or not all pregnant women in the U.S. should be screened for subclinical hypothyroidism or hypothyroxinemia.
Pregnant women less than 20 weeks gestation will have a blood test to screen for subclinical hypothyroidism or hypothyroxinemia. If eligible for the trial, patients will receive levothyroxine or placebo until delivery. Blood draws will be done at monthly study visits and the dosage will be adjusted based on test results. The children of these patients will have developmental testing done annually until they are 5 years of age.
Comparison(s): thyroxine supplementation versus placebo given during pregnancy to determine whether therapy is effective in improving intellectual ability at 5 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical Hypothyroidism, Hypothyroxinemia, Pregnancy
Keywords
Subclinical Hypothyroidism, Hypothyroxinemia, Thyroid, Pregnancy, Intellectual Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levothyroxine for Subclinical Hypothyroidism
Arm Type
Experimental
Arm Description
100 µg of Levothryoxine for participants with subclinical hypothyroidism
Arm Title
Placebo for Levothyroxine - Subclinincal Hypothyroidism
Arm Type
Placebo Comparator
Arm Description
Placebo for Levothyroxine for participants with subclinical hypothyroidism
Arm Title
Levothyroxine for Hypothyroxinemia - Hypothyroxinemia
Arm Type
Experimental
Arm Description
50 µg of Levothyroxine for participants with hypothyroxinemia
Arm Title
Placebo for Levothyroxine
Arm Type
Placebo Comparator
Arm Description
Placebo for Levothyroxine for participants with hypothyroxinemia
Intervention Type
Drug
Intervention Name(s)
Levothyroxine
Intervention Description
Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery.
Intervention Type
Drug
Intervention Name(s)
Placebo for Levothyroxine
Primary Outcome Measure Information:
Title
Intellectual Function of Children at 5 Years of Age in Women Diagnosed With a) Subclinical Hypothyroidism or b) Hypothyroxinemia During the First Half of Pregnancy, or Death.
Description
The primary outcome was death or IQ score at 5 years of age (or at 3 years of age if the 5-year examination was missing). The full-scale IQ was assessed with the use of the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age or the overall (general conceptual ability) score from the Differential Ability Scales-II at 3 years of age if the WPPSI-III score was not available. Results are expressed as an age-standardized score, with an expected population mean of 100 and a standard deviation of 15. Death before 3 years of age was assigned a score of 0 (lowest possible rank) and was included in the estimation of the median.
For Quotient and Composite score:
below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+
Time Frame
60 months of age
Secondary Outcome Measure Information:
Title
Week of Gestation at Delivery
Description
Gestational age at delivery and preterm birth < 37 weeks' gestation or < 34 weeks' gestation
Time Frame
Delivery
Title
Number of Participants With Preterm Delivery
Description
Preterm delivery at less than 37 weeks or less than 34 weeks gestation
Time Frame
Delivery
Title
Selected Cognitive Abilities From the Subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III)
Description
Standardized full-scale IQ scores from the Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III) at 5 years of age. Quotient and Composite scores have a mean of 100 and a standard deviation of 15. Subtest scaled scores have a mean of 10 and a standard deviation of 3.
For Quotient and Composite score:
below 70 is Extremely Low, 70-79 is Borderline, 80-89 is Low Average, 90-109 is Average, 110-119 is High Average, 120-129 is Superior, 130+ is Very Superior.
Time Frame
60 months
Title
Cognitive and Achievement Levels From the Differential Ability Scales (DAS II)
Description
Overall general conceptual ability score as measured by the DAS-II at 36 months of age.
GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low
≤ 69 Very low
Time Frame
36 months
Title
Cognitive and Achievement Levels From Two DAS-II Subtests (Recall of Digits Forward and Recognition of Pictures)
Description
Cognitive and achievement levels from two DAS-II subtests (Recall of Digits Forward and Recognition of Pictures)
GCA General Conceptual Ability Classification ≥ 130 Very high 120-129 High 110-119 Above average 90-109 Average 80-89 Below average 70-79 Low
≤ 69 Very low
Time Frame
48 months of age
Title
Cognitive, Motor and Language Scale Scores From the Bayley Certified Scales of Infant Development III Edition
Description
Composite scores are derived for cognitive, language, and motor development and scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Results can also be expressed as percentile ranks relative to the standardization sample, with a mean and median of 50 and range from 1 to 99
Time Frame
12 and 24 months of age
Title
Behavioral Problems and Social Competencies at 36 and 60 Months of Age, as Measured by the Child Behavior Checklist (CBCL)
Description
Behavioral problems and social competencies at 36 and 60 months of age, as measured by the Child Behavior Checklist (CBCL). The CBCL is filled out by the caregiver. Each of the 100 questions indicates a behavior for which the caregiver scores as Not True (0), Sometimes True (1), or Often True (2). The scores for all the questions are then summed and evaluated against the normative data/T-scores. A Tscore of less than 60 is considered to be in the normal range. A T score of 60-63 is a borderline, and a T score of more than 63 is in the clinical range. Lower scores represent better outcomes.
Time Frame
36 and 60 months of age
Title
Attention Deficit Hyperactivity Disorder (ADHD) Index Score From the Connors' Rating Scales (Parent-S) - Revised
Description
The Conners' Rating Scales-Revised were used to assess attention deficit-hyperactivity disorder (ADHD). A T score of 45 to 55 is considered to be typical or average; a T score of 44 or less is not a concern, a T score of 56 to 60 is considered to be a borderline score, and a T score of 61 or higher indicates a possible or clinically significant problem.
Time Frame
48 months of age
Title
Participants With Placental Abruption
Description
Clinically significant placental abruption will be determined by centralized (blinded) chart review
Time Frame
Duration of pregnancy, delivery
Title
Participants With Gestational Hypertension
Description
Gestational hypertension defined as patient having a diastolic ≥ 90 during pregnancy without proteinuria
Time Frame
During pregnancy and until delivery
Title
Participants With Preeclampsia
Description
Preeclampsia defined as patient having a diastolic ≥ 90 during pregnancy with at least 1 + proteinuria. Preeclampsia will also include HELLP syndrome or eclampsia.
Time Frame
Duration of pregnancy, Delivery
Title
Gestational Diabetes Mellitus
Description
A patient is considered to have gestational diabetes if clinically diagnosed with class A1 or A2
Time Frame
During pregnancy until delivery
Title
Participants With Composite Neonatal Outcome
Description
The composite neonatal outcome was defined as periventricular leukomalacia, intraventricular hemorrhage of grade III or IV, necrotizing enterocolitis (stage ≥II), severe retinopathy of prematurity (stage ≥III), the severe respiratory distress syndrome, bronchopulmonary dysplasia, neonatal death, stillbirth, or serious infectious complication.
Time Frame
Within 72 hours of delivery.
Title
Participants Who Experienced a Stillbirth or Miscarriage
Description
Stillbirth or miscarriage.
Time Frame
Delivery
Title
Number of Neonatal Deaths
Description
Fetal and neonatal death
Time Frame
Through 72 hours post delivery
Title
Number of Infants With Apgar Score 4 at 1 Minute and < 7 at 5 Minutes
Description
Apgar score < 4 at 1 minute and < 7 at 5 minutes
Time Frame
1 minute and 5 minutes post delivery
Title
Number of Infants Admitted to NICU
Description
Admission to NICU
Time Frame
Delivery
Title
Infants With Birth Weight < 10th Percentile (Gestational Age z Score)
Description
Birth weight < 10th percentile (gestational age z score)
Time Frame
Delivery
Title
Neonatal Head Circumference (Centimeters)
Description
Neonatal head circumference measured within 24 hours of birth. This measurement is included based on a report showing that maternal treatment with thyroxine for overt hypothyroidism was associated with reduced head circumference in the newborn infant
Time Frame
Within 24 hours of birth
Title
Number of Infants With Respiratory Distress Syndrome
Description
Respiratory distress syndrome (RDS) will be defined based on a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 ≥ 0.40) for greater than or equal to 24 hours. For infants dying before 24 hours of age, a clinical diagnosis of RDS Type I and oxygen therapy (FiO2 ≥ 0.40) are sufficient.
Time Frame
Delivery and greater than or equal to 24 hours
Title
Number of Infants With Retinopathy or Prematurity
Description
This diagnosis will be reached when an ophthalmologic examination of the retina has been performed and ROP is diagnosed at Stage I (demarcation line in the retina) or greater
Time Frame
Through 72 hours of birth
Title
Number of Infants With Necrotizing Enterocolitis
Description
Necrotizing enterocolitis (NEC) is defined by the following: the unequivocal presence of intramural air on abdominal x-ray, perforation seen on abdominal x-ray, clinical evidence as suggested by erythema and induration of the abdominal wall, or intra-abdominal abscess formation, or stricture formation observed at surgery or autopsy following an episode of suspected NEC. The condition is classified based on the Bell staging system
Time Frame
Delivery within 2 weeks of birth
Title
Number of Infants With Bronchopulmonary Dysplasia
Description
Bronchopulmonary dysplasia (BPD) is defined as the need for supplemental oxygen at 36 weeks corrected age, for babies born <34 weeks by project gestational age only
Time Frame
Through 72 hours post delivery
Title
Number of Infants With Respiratory Therapy Greater Than or Equal to 1 Day
Description
oxygen therapy (FiO2 ≥ 0.40) for greater than or equal to 24 hours
Time Frame
72 hours post delivery
Title
Number of Days in the Hospital Nursery
Description
Median number of days in the hospital nursery
Time Frame
Through hospital discharge
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subclinical Hypothyroidism as defined by an elevated TSH (≥ 3.00 mU/L) and a free-T4 in the normal range (i.e. 0.86 to 1.90 ng/dL) or Hypothyroxinemia as defined by a TSH in the normal range (0.08 to 2.99 micrometers (mU)/L) and a low free-T4 (<0.86 ng/dL)
Singleton Pregnancy
Gestational age at randomization between 8 weeks 0 days and 20 weeks 6 days
Exclusion Criteria:
Major fetal anomaly or demise
Planned termination of the pregnancy
History of thyroid cancer or current thyroid disease requiring medication
Diabetes, on medication (insulin, glyburide)
Collagen vascular disease (autoimmune disease), such as lupus, scleroderma and polymyalgia rheumatica, on medication
Receiving anticoagulant therapy
Depression, currently on treatment with tricyclics or selective serotonin reuptake inhibitors (SSRIs)
Other known serious maternal medical complications including:
Chronic hypertension requiring antihypertensive medication (including diuretics)
Epilepsy or other seizure disorder, on medication
Active or chronic liver disease (acute hepatitis, chronic active hepatitis) with persistently abnormal liver enzymes
Cancer (including melanoma but excluding other skin cancers)
Heart disease (tachyrhythmia, class II or greater heart disease or on heart medication). Mitral valve prolapse without arrhythmia is not an exclusion.
Asthma, on oral corticosteroids
Known illicit drug or alcohol abuse during current pregnancy
Delivery at a non-network hospital
Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
Unwilling or unable to commit to 5 year follow-up of the infant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Casey, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Menachem Miodovnik, MD
Organizational Affiliation
NICHD Project Scientist
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Case Western University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University of Texas - Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Medical Branch - Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Texas-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared after the completion of the trial and publication of the main analyses per NIH policy. When made available, requests for the dataset(s) can be sent to mfmudatasets@bsc.gwu.edu.
Citations:
PubMed Identifier
34856574
Citation
Smid MC, Metz TD, McMillin GA, Mele L, Casey BM, Reddy UM, Wapner RJ, Thorp JM, Saade GR, Tita ATN, Miller ES, Rouse DJ, Sibai B, Costantine MM, Mercer BM, Caritis SN; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Prenatal Nicotine or Cannabis Exposure and Offspring Neurobehavioral Outcomes. Obstet Gynecol. 2022 Jan 1;139(1):21-30. doi: 10.1097/AOG.0000000000004632.
Results Reference
derived
PubMed Identifier
28249134
Citation
Casey BM, Thom EA, Peaceman AM, Varner MW, Sorokin Y, Hirtz DG, Reddy UM, Wapner RJ, Thorp JM Jr, Saade G, Tita AT, Rouse DJ, Sibai B, Iams JD, Mercer BM, Tolosa J, Caritis SN, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Treatment of Subclinical Hypothyroidism or Hypothyroxinemia in Pregnancy. N Engl J Med. 2017 Mar 2;376(9):815-825. doi: 10.1056/NEJMoa1606205.
Results Reference
derived
Links:
URL
http://www.bsc.gwu.edu/mfmu/Projects/Projects.cgi
Description
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Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
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