Protocol summary
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Study aim
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Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody.
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Design
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]n the first stage thyroid hormones are tested in 160 pregnant women in the first 20 weeks of pregnancy and pregnant women with subclinical hypothyroidism and TPOAb negative are identified. The urines of these women are also sampled for iodine measurement. The second stage is a parallel group randomised clinical trial with control group, community based and one blinded study. it is phase two of clinical trials. In the second stage of study, pregnant women with subclinical hypothyroidism and negative TPOAb are divided simple randomly into two groups using permuted block randomization . The first group, intervention group, is treated with levothyroxine. The second group, as control group did not receive intervention.In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery.
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Settings and conduct
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Data collection from pregnant women is done in prenatal care clinics. A comprehensive questionnaire including demographics, reproductive, medical and prenatal history was completed. Thyroid tests are performed to diagnose pregnant women with subclinical hypothyroidism TPOAb negative.
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Participants/Inclusion and exclusion criteria
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pregnant women during the first 20 weeks of pregnancy should not have contraindications for taking levothyroxine contraindication of
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Intervention groups
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The intervention group, is treated with levothyroxine. The control group does not receive intervention.
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Main outcome variables
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Abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membranes and third trimester hemorrhage
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2013121214849N3
Registration date:
2014-01-06, 1392/10/16
Registration timing:
registered_while_recruiting
Last update:
2018-07-17, 1397/04/26
Update count:
1
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Registration date
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2014-01-06, 1392/10/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2013-10-23, 1392/08/01
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Expected recruitment end date
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2015-03-20, 1393/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
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Public title
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The effect of Levothyroxine on pregnancy outcome of pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: pregnant women during the first 20 weeks of pregnancy.
Exclusion criteria:
contraindication of Levothyroxine use include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
1600
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Study subjects are randomly divided into two groups using permuted block randomization to achieve balance across treatment groups. The number of subjects per block will be four.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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A sealed opaque envelope will be assigned to each subject, only the midwife treating the women, who will not participate in any subsequent phase of the study, knows in which group each patient is.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-10-15, 1392/07/23
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Ethics committee reference number
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33ECRIES92/07/23
Health conditions studied
1
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Description of health condition studied
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Abortion
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ICD-10 code
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O03
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ICD-10 code description
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Spontaneous abortion
2
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Description of health condition studied
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Preterm labor
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ICD-10 code
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O60
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ICD-10 code description
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Preterm labour and delivery
3
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Description of health condition studied
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Low birth weight
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ICD-10 code
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P07
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ICD-10 code description
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Disorders related to short gestation and low birth weight, not elsewhere classified
4
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Description of health condition studied
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Intra uterine growth restriction
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ICD-10 code
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P05
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ICD-10 code description
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Slow fetal growth and fetal malnutrition
5
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Description of health condition studied
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Premature rupture of membranes
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ICD-10 code
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O42
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ICD-10 code description
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Premature rupture of membranes
6
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Description of health condition studied
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Third trimester hemorrhage
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ICD-10 code
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O44 , O45
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ICD-10 code description
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Placenta previa, Premature separation of placenta [abruptio placentae]
Primary outcomes
1
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Description
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Abortion
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Timepoint
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Up to 20 weeks of pregnancy (In cases that intervention begins in first trimester)
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Method of measurement
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Checklist
2
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Description
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Preterm labor
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Timepoint
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20 to 37 weeks of pregnancy (within 1 to 6 months after intervention)
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Method of measurement
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Checklist
3
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Description
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Low birth weight
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Timepoint
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After birth (5 to 7 months after intervention)
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Method of measurement
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Checklist
4
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Description
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Intra uterine growth restriction
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Timepoint
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5 to 7 months after intervention
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Method of measurement
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Checklist
5
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Description
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Premature rupture of membranes (PROM)
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Timepoint
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5 to 7 months after intervention
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Method of measurement
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Checklist
6
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Description
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Third trimester hemorrhage
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Timepoint
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Third trimester (2 to 5 months after intervention)
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Method of measurement
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Checklist
7
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Description
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TSH level of newborn at birth (day 3 to5 births)
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Timepoint
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3 to 5 days after birth (5 to 7 months after intervention)
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Method of measurement
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Immunoradiometric assay (IRMA)
Secondary outcomes
1
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Description
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Thyroid hormones (T4, T3 uptake, TSH) in second and third trimester
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Timepoint
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20th and 30th week of pregnancy
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Method of measurement
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T4: Radioimmuno assay (RIA), TSH: Immunoradiometric assay (IRMA), T3uptake: ELISA
2
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Description
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Blood pressure
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Timepoint
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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
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Method of measurement
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Blood pressure measuring devices
3
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Description
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Edema
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Timepoint
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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)
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Method of measurement
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Checklist
4
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Description
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Fetal heart rate (FHR)
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Timepoint
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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
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Method of measurement
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Pinard Stethoscope
5
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Description
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Headache
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Timepoint
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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)
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Method of measurement
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Checklist
6
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Description
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Vaginal bleeding
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Timepoint
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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
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Method of measurement
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Checklist
7
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Description
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Uterine contractions
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Timepoint
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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)
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Method of measurement
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Checklist
8
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Description
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Type of delivery
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Timepoint
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Delivery (5 to 7 months after intervention)
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Method of measurement
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Checklist
9
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Description
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Postpartum atonia
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Timepoint
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Postpartum (5 to 7 months after intervention)
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Method of measurement
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Checklist
10
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Description
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Postpartum hemorrhage
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Timepoint
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Postpartum (5 to 7 months after intervention)
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Method of measurement
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Checklist
11
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Description
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Newborn Apgar
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Timepoint
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After birth (5 to 7 months after intervention)
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Method of measurement
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Apgar Apgar scoring
12
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Description
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Hospitalization in neonatal intensive care unit (NICU)
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Timepoint
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After birth (5 to 7 months after intervention)
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Method of measurement
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Checklist
13
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Description
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Newborn convulsion
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Timepoint
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After birth (5 to 7 months after intervention)
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Method of measurement
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Checklist
14
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Description
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Newborn icterus
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Timepoint
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After birth (5 to 7 months after intervention)
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Method of measurement
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Checklist
Intervention groups
1
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Description
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Intervention group will treat with Levoxine (Levothyroxine sodium). These patients will receive 1 mg per kg of body weight daily levothyroxine. Dosages will maintain throughout pregnancy until delivery. In this study are used from Levothyroxine sodium 0.1 mg manufactured by Iran Hormone.
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Category
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Treatment - Drugs
2
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Description
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The control group does not receive intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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