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Sponsored by: |
Oklahoma State University Center for Health Sciences |
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Information provided by: | Oklahoma State University Center for Health Sciences |
ClinicalTrials.gov Identifier: | NCT00826605 |
The purpose of this study, then, is to search existing clinic and hospital records for answers to the following two questions: (1) Do pregnant women who are at least 37 weeks gestation and who have an increase in urubilinogen on urine dipstick at a prenatal appointment have a statistically significant shorter average time before going into active labor than their negative counterparts? (2) Do pregnant women who are at least 37 weeks gestation and who show a modest weight loss between two prenatal appointments have a statistically significant shorter average time before going into active labor than their counterparts who did not lose weight?
Condition |
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Increase in Urobilinogen in Urine Prior to Delivery Weight Loss After 37 Weeks Gestation Prior to Delivery |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Retrospective Investigation of Presence of Urobilinogen and Maternal Weight Loss as Indications of Impending Parturition in the Term Gravida |
Estimated Enrollment: | 200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Urobilinogen increase
Increase in urobilinogen increase on routine dipstick test at prenatal appointment after 37 weeks gestation
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Weight Loss at Term
Weight loss since previous prenatal appointment after 37 weeks gestation
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Ages Eligible for Study: | 18 Years to 34 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Population is mothers between the ages of 18 and 34 years of age with a single intrauterine pregnancy between 37 weeks and 41 weeks gestational age.
(Both very young mothers and women 35 and older have increased risk of premature delivery.) The patients will have an admission diagnosis of either active labor or spontaneous rupture of membranes. Active labor is defined as uterine contractions resulting in changes either in the cervical dilatation, the effacement of the cervix and/or descent of the fetal head in the pelvis.
Inclusion Criteria: Our study population will consist of women between the ages of 18 and 34 who delivered a single, viable, term infant at OSU Medical Center between January 1, 2002 and December 31, 2006. Gestational age must be greater than 37 weeks and less than 41 weeks, as ascertained by certain last menstrual period and/or first trimester ultrasound. The chart must include a diagnosis of active labor or spontaneous rupture of membranes, and the patient must have had at least two third-trimester prenatal checkups at OSU Houston Center OB/GYN, including one during the last two weeks of gestation. We will define a term infant as 37 weeks gestation or greater (3). Our study population will consist of mainly Medicaid patients.
The ethnic blend of our study population will include Caucasian, African-American, Hispanic, American Indian, and Asian women.
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Exclusion Criteria: We will exclude women with multiple gestation, because they are at risk of preterm labor. We will also exclude anyone else who had preterm delivery. In addition, we will exclude women with a diagnosis of liver disease, including intrahepatic cholestasis and hepatitis, chronic hypertension, intraamniotic infection, preeclampsia or its variant, HELLP syndrome, cholelithiasis, inadequate prenatal care, preterm labor, or induction of labor (other than due to premature rupture of membranes).
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Contact: Elizabeth Harris, DO | 918-586-4500 | drsharris@cox.net |
Contact: Sarah McCoy, PhD | 981-274-0639 | sjmccoy98@aol.com |
United States, Oklahoma | |
OSU Medical Center | Recruiting |
Tulsa, Oklahoma, United States, 74127 | |
Contact: Teri Bycroft, MSN 918-586-4609 teri.bycroft@okstate.edu | |
OSU Houston Center OB/Gyn Clinic | Recruiting |
Tulsa, Oklahoma, United States, 74127 | |
Contact: Teri Bycroft, MSN 918-586-4609 teri.bycroft@okstate.edu |
Principal Investigator: | Elizabeth Harris, DO | OSU Center for Health Sciences |
Responsible Party: | Oklahoma State University Center for Health Sciences ( Elizabeth Harris, DO, OB/Gyn Resident ) |
Study ID Numbers: | 200802 |
Study First Received: | January 20, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00826605 History of Changes |
Health Authority: | United States: Institutional Review Board |
Weight loss, urobilinogen |
Body Weight Signs and Symptoms Weight Loss Body Weight Changes |
Body Weight Signs and Symptoms Weight Loss Body Weight Changes |