A Randomized Trial of 17 Hydroxyprogesterone Caproate (17P)
for
Prevention of Preterm Birth in Nulliparous Women with a Short
Cervix
- The purpose of this trial is to determine whether treatment
with progesterone (17P), initiated after 16 weeks but before
23 weeks of gestation, reduces the risk of a preterm delivery
(before 37 weeks) in nulliparous women with a a short cervix (less than
30 mm).
- Are between 16-22 weeks gestation
- Have a single-fetal pregnancy
- Have never delivered a baby after 19 weeks of pregnancy
- Cervix measures less than 30 mm (1.2 inches)
- A study-certified ultrasonographer will measure your cervix
using vaginal ultrasound.
- If your cervix measures less than 1.2 inches (30 mm), a
nurse may ask you if you are interested in participating in a
randomized, placebo controlled study of progesterone in pregnancy.
- If you consent to the trial, you will get weekly injections
containing 250 mg of either progesterone or placebo oil
in the muscle of your buttocks until either you deliver or you
reach 37 weeks of pregnancy.
- Information will be collected on your pregnancy, medical
procedures, labor and the status of your baby.
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Combined Antioxidant and Preeclampsia Prediction
Studies
A Randomized Clinical Trial of Antioxidants to Prevent
Preeclampsia
- The purpose of this study is to determine whether antioxidants
(Vitamins C and E) reduce the frequency of serious maternal and
infant complications associated with pregnancy-related high blood
pressure (preeclampsia)
- Are between 9-12 weeks gestation
- Have a single-fetal pregnancy
- Have never given birth before
- Have a blood pressure less than 135/85
- Have 0 to trace elements of protein in the urine
- Are not taking Vitamin C or E in amounts greater than that
found in prenatal vitamins
- Enrolled patients will take 1000 mg Vitamin C "&" 400
IU of Vitamin E or placebo daily until delivery.
- Patients will be seen every 4 weeks to count pills, dispense
study capsules, assess side effects, and to measure blood
pressure, weight and protein in the urine. Blood and urine
samples will be taken at specific intervals during the pregnancy.
- The knowledge we gain from this study may provide us with
information on how to prevent or treat preclampsia in the future.
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Combined Antioxidant and Preeclampsia Prediction
Studies
An Observational Cohort Study to Predict
Preeclampsia
- The purpose of this study is to determine if changes in
concentrations of biochemical markers in blood and urine,
and/or changes in biophysical markers (e.g., blood pressure,
weight, body fat) measured throughout gestation can predict
the development of preeclampsia (pregnancy-related high
blood pressure).
- Must be enrolled in CAPPS randomized clinical trial
- Are between 9-12 weeks gestation
- Have a single-fetal pregnancy
- Have never given birth before
- Have a blood pressure less than 135/85
- Have 0 to trace elements of protein in the urine
- Are not taking Vitamin C or E in amounts greater than that
found in prenatal vitamins
- At specific intervals throughout your pregnancy and
after you give birth some procedures will be completed in
addition to your normal care. These include the collection
of blood and urine samples, a CBC, measurements of waist
and hip, an ultrasound of your uterine arteries to measure
blood flow and DNA testing. The knowledge that we gain may
give us information about how to predict which women may be
at risk for preeclampsia in the future.
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A Randomized Trial of Treatment for
Mild Gestational Diabetes Mellitus
- The purpose of this study is to see if diet therapy
and blood sugar monitoring will affect pregnancy outcomes,
including reducing the risk of problems for newborns, such
as low blood sugar, jaundice, large babies and other
pregnancy outcomes, in pregnant women who have mild
gestational diabetes.
- Are 24-31 weeks gestation
- If there is an indication that you have mild
gestational diabetes
- If you are diagnosed as having mild gestational
diabetes you will be enrolled in one of two groups. One
group of women will receive standard pregnancy care while
the other groups will receive diet therapy and be taught
how to self-monitor their blood sugar level. The knowledge
gained from this study may help improve our ability to help
patients in the future that have been diagnosed with mild
gestational diabetes.
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A Randomized Trial of Thyroxine Therapy
for Subclinical Hypothyroidism or Hypothyroxinemia
Diagnosed During Pregnancy
- This trial is being conducted 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.
- Are between 8-20 weeks gestation
- Are pregnant with one fetus
- A test of your blood shows that your thyroid gland is mildly
under-active resulting in one of two conditions: subclinical
hypothyroidism or hypothyroxinemia
- Enrolled patients will take levothyroxine supplements (thyroid
replacement) or placebo daily until delivery.
- Patients will be seen every 4 weeks to count remaining capsules
of study medication, dispense study medication for the following
4 weeks, and to assess any side effects. Blood draws will be done
at these study visits and the dosage will be adjusted based on test
results.
- The children who are born to enrolled patients will have
developmental testing done each year until age 5.
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