Phase 3
N=1,203
Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy
Subclinical Hypothyroidism · Hypothyroxinemia · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00388297 ↗Enrolled (actual)
1,203
Serious AEs
0.9%
Results posted
Jan 2019
Primary outcome: Primary: 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. — 97; 94; 94; 91 score on a scale — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Levothyroxine (Drug); Placebo for Levothyroxine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- The George Washington University Biostatistics Center
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
97; 94; 94; 91 | 0.71 |
| SECONDARY Week of Gestation at Delivery |
39.1; 38.9; 39.0; 38.8 | 0.57 |
| SECONDARY Number of Participants With Preterm Delivery |
9; 10; 10; 7; 31; 37 | 0.81 |
| SECONDARY Selected Cognitive Abilities From the Subscales of the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) |
97; 95; 94; 92 | 0.89 |
| SECONDARY Cognitive and Achievement Levels From the Differential Ability Scales (DAS II) |
90; 90; 90; 89 | 0.90 |
| SECONDARY Cognitive and Achievement Levels From Two DAS-II Subtests (Recall of Digits Forward and Recognition of Pictures) |
84; 84; 91; 74; 74; 74 | 0.60 |
| SECONDARY Cognitive, Motor and Language Scale Scores From the Bayley Certified Scales of Infant Development III Edition |
100; 100; 100; 100; 97; 97 | 0.63 |
| SECONDARY Behavioral Problems and Social Competencies at 36 and 60 Months of Age, as Measured by the Child Behavior Checklist (CBCL) |
46; 46; 48; 48; 44; 44 | 0.99 |
| SECONDARY Attention Deficit Hyperactivity Disorder (ADHD) Index Score From the Connors' Rating Scales (Parent-S) - Revised |
48; 49; 50; 49 | 0.37 |
| SECONDARY Participants With Placental Abruption |
1; 5; 3; 2 | 0.12 |
| SECONDARY Participants With Gestational Hypertension |
33; 36; 20; 24 | 0.69 |
| SECONDARY Participants With Preeclampsia |
22; 20; 9; 11 | 0.76 |
| SECONDARY Gestational Diabetes Mellitus |
25; 22; 21; 24 | 0.66 |
| SECONDARY Participants With Composite Neonatal Outcome |
7; 12; 5; 7 | 0.24 |
| SECONDARY Participants Who Experienced a Stillbirth or Miscarriage |
4; 7; 2; 5 | 0.36 |
| SECONDARY Number of Neonatal Deaths |
0; 1; 1; 1 | 0.50 |
| SECONDARY Number of Infants With Apgar Score 4 at 1 Minute and < 7 at 5 Minutes |
6; 7; 6; 7; 2; 3 | 0.76 |
| SECONDARY Number of Infants Admitted to NICU |
29; 21; 31; 31 | 0.24 |
| SECONDARY Infants With Birth Weight < 10th Percentile (Gestational Age z Score) |
33; 27; 23; 20 | 0.45 |
| SECONDARY Neonatal Head Circumference (Centimeters) |
33.9; 33.9; 33.9; 34.2 | 0.46 |
| SECONDARY Number of Infants With Respiratory Distress Syndrome |
9; 6; 4; 5 | 0.45 |
| SECONDARY Number of Infants With Retinopathy or Prematurity |
1; 0; 0; 0 | 1.00 |
| SECONDARY Number of Infants With Necrotizing Enterocolitis |
1; 1; 2; 0 | 1.00 |
| SECONDARY Number of Infants With Bronchopulmonary Dysplasia |
0; 1; 0; 1 | 0.50 |
| SECONDARY Number of Infants With Respiratory Therapy Greater Than or Equal to 1 Day |
11; 11; 13; 12 | 0.99 |
| SECONDARY Number of Days in the Hospital Nursery |
2; 2; 2; 2 | 0.43 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00388297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.