Research -- Maternal Fetal Medicine
Involvement in research studies keeps our team at the forefront of the latest developments in maternal fetal medicine. Studies implemented by the Division of Maternal Fetal Medicine are advancing original knowledge in the field. This ensures that our patients benefit from the most current approaches to care during pregnancy. The National Institutes of Health supports a number of our studies, including the following: - The Vaginal Ultrasound Cerclage Trial: Both a prior preterm delivery and cervical length, as measured by vaginal ultrasound, have been reported to be powerful predictors of subsequent spontaneous preterm birth. Cervical cerclage has been empirically recommended to treat women with sonographic findings suggesting "cervical incompetence," in spite of the fact that this therapy is expensive, carries risks, and has not been proven effective in randomized clinical trials. In order to evaluate the potential clinical utility of cerclage in women with findings suggestive of cervical incompetence on vaginal ultrasound, the need for a randomized trial has been identified. This multicenter randomized clinical trial of cerclage in women with a prior spontaneous preterm birth who have a shortened cervical length <25 mm at 16.0 to 22.6 week's gestation will determine if this surgical intervention decreases the incidence of spontaneous preterm birth prior to 35 weeks' gestation.
Advances made through these and other studies not only benefit our patients but also expand knowledge worldwide as new developments are shared throughout the medical research community. The Division of MFM is a member of the Maternal Fetal Medicine Unit Network (MFMU), an umbrella organization created by the National Institute of Child Health and Human Development (NICHD). The Maternal Fetal Medicine Unit is comprised of fourteen academic clinical centers across the country. The purpose of the MFMU is to improve maternal and neonatal outcomes while assessing efficacy, safety and cost effectiveness of perinatal interventions. The network is currently involved in 4 randomized clinical trials at Columbia University Medical Center, CHONY and the Allen Pavilion, and their affiliations. Beneficial Effects of Antenatal Magnesium Sulfate Administration (BEAM) will assess whether giving magnesium sulfate will reduce the incidence of cerebral palsy in preterm infants whose mothers received it prior to birth. - Eligible patients are <32 wks, PPROM, PTL or need for immediate delivery
- Patient may not be receiving tocolytic therapy
- Magnesium vs. Placebo
- 6 month, 12 month and 24 month infant follow-up
- Projected to complete all follow-up activities in January, 2007
Mild Gestational Diabetes Mellitus Study (GDM) will assess whether dietary treatment and insulin therapy as needed, will reduce risks of neonatal morbidity associated with mild maternal carbohydrate intolerance. - Eligible Patients have a singleton pregnancy, no prior hx of gestational diabetes
and present with mildly elevated glucose tolerance test at 24-29 weeks GA - Randomized to close blood glucose monitoring, diet counseling and treatment as needed, versus routine standard of care.
- Projected to complete enrollment by end of summer, 2007.
- Columbia is the second-highest recruiting center for this study.
Clinical Trial of Antioxidants to prevent Preeclampsia (CAPPS) will assess whether antioxidant ( Vit .C and E) supplementation initiated in early pregnancy will reduce the frequency of serious maternal and fetal complications from pregnancy related hypertension and PEC. - Eligible patients are nulliparous with singleton pregnancies and no history of major medical illness
- Randomized to daily Vitamin C (1000 mg) and Vitamin E (400 IU) vs. placebo.
- Study started in July 2003, planning to enroll 10,000 women.
- Projected to complete enrollment by end of summer, 2007
TSH is 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 during pregnancy, with thyroid hormone replacement affects their children's intellectual development at 5 years of age. - Participants are between 8 and 20 weeks gestation and pregnant with one fetus.
- A blood test is done for thyroid hormone levels. If it shows the thyroid gland to be mildly under-active, resulting in one of two conditions, the patient would be eligible for the randomized trial.
- 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 four weeks, and to assess any side effects. Blood draws will be done at these study visits and the dosage will be adjusted based on results.
- The children who are born to enrolled parents will have developmental testing done each year until age 5.
Contact Us If you have any questions about any of the MFMU studies or would like to enroll a patient, please contact us at: 212 305 2169 or Pager: # 212 305 5880 PIN # 84MFM or 84636
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