National Institute of Child Health and Human Development
Maternal-Fetal Medicine Units Network

Studies Currently Recruiting

Following are the clinical trials in the NICHD MFMU Network that are still in the recruitment phase. If you are interested in participating in one of the following studies or would like additional information, please contact the clinical center nearest to you.

What is the purpose of the research study?

• 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).

Who is eligible to participate?
You may be eligible to participate if you meet the following criteria:

• 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)

What is involved?

• 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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What is the purpose of the research study?

• 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.

Who is eligible to participate?
You may be eligible to participate if you meet the following criteria:

• 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

What is involved?

• 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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