Enrolling studies

WOMB's Currrent Projects

TITLE: Randomized study to compare the Cook Cervical Ripening Balloon plus Pitocin to Pitocin alone in PROM (Preterm Premature Rupture of Membrane ) patients
SPONSOR: Cook Incorporated
BRIEF ABSTRACT: This is a prospective, controlled, randomized, single-center study to compare the effectiveness and safety of the CRB plus Pitocin to Pitocin alone in term and near term PROM patients not in labor
TITLE: Removal versus Retention of Cerclage in Preterm Premature Rupture of Membrane (PROM)
SPONSOR: Obstetrix Medical Group
BRIEF ABSTRACT: To determine whether retention of cerclage after PPROM improves latency and lessens neonatal morbidity.
TITLE: Growth and Tolerance of Young Infants Fed Infant Formulas
SPONSOR: Abbott Nutrition, Abbott Laboratories
BRIEF ABSTRACT: To compare growth and tolerance of healthy term infants fed experimental infants formulas with 0.2 g/L or 1.0 g/L Fucosyllactose (2FL) with a commercial infant formula and human breast milk.
TITLE: Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) (17PinPROM)
SPONSOR: Obstetrix Medical Group
BRIEF ABSTRACT: To determine if a weekly dose of 17P given to women in PROM will: (a) Increase the probability of continuing the pregnancy until a favorable gestational age. (b) Increase the interval between randomization & delivery. (c) Decrease neonatal morbidity.
TITLE: Clinical Evaluation of the Actim Partus Test
SPONSOR: Alere Scarborough, Inc.
BRIEF ABSTRACT: A prospective, multi-center study designed to evaluate the clinical test performance characteristics-i.e., the negative diagnostic likelihood ratio, as well as the positive diagnostic likelihood ratio, sensitivity and specificity, positive predictive value and negative predictive value-of the Actim Partus test in cervical secretions of pregnant women between week 21+6 and week 35+6 gestation presenting with intact fetal membranes, minimal cervical dilation (<3cm) and signs and/or symptoms suggestive of and whereby the clinical suspects preterm labor.
TITLE: A Family Alliance Intervention for Pregnant Women
SPONSOR: WOMB/ Formerly Arizona Biomedical Research Commission
BRIEF ABSTRACT: The proposed research project will consist of a randomized trial in pregnant women who admit to smoking will be randomized to one of the two groups:

1. Smoking Cessation or Reduction in Pregnancy Treatment (SCRIPT- pregnant patient specific cessation counseling)
2. Family –Alliance cessation counseling + ultrasound (patient and significant other)
TITLE: A phase 3B, Multi-Center, Randomized, Double Blind study of Hydroxyprogesterone Caproate Injection, 250 mg/ml, Versus vehicle for the prevention of preterm birth in women with a previous single spontaneous preterm delivery
SPONSOR: Ther-Rx Co. / formerly KV Pharmaceutical Co.
BRIEF ABSTRACT: This study is a multi-center, randomized, double blind, vehicle-controlled clinical trial. Subjects will be assessed and receive weekly injections of study drug from randomization (160 through 206 weeks of gestation) until 366 weeks of gestation or delivery, whichever occurs first.
TITLE: A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
SPONSOR: Ther-Rx Co. / formerly KV Pharmaceutical Co.
BRIEF ABSTRACT: In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).