Urobilinogen, Maternal Weight Loss and Impending Parturition at Term

This study has been completed.
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00826605
First received: January 20, 2009
Last updated: January 26, 2010
Last verified: January 2010
  Purpose

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
Increase in Urobilinogen in Urine Prior to Delivery
Weight Loss After 37 Weeks Gestation Prior to Delivery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Investigation of Presence of Urobilinogen and Maternal Weight Loss as Indications of Impending Parturition in the Term Gravida

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:
  • Increase in urobilinogen on routine urine dipstick at prenatal appointment, term pregnancy [ Time Frame: none--chart review ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal weight loss at term before giving birth [ Time Frame: none--chart review ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Urobilinogen increase
Increase in urobilinogen increase on routine dipstick test at prenatal appointment after 37 weeks gestation
Weight Loss at Term
Weight loss since previous prenatal appointment after 37 weeks gestation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826605

Locations
United States, Oklahoma
OSU Houston Center OB/Gyn Clinic
Tulsa, Oklahoma, United States, 74127
OSU Medical Center
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Elizabeth Harris, DO OSU Center for Health Sciences
  More Information

No publications provided

Responsible Party: Elizabeth Harris, DO, OB/Gyn Resident, Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT00826605     History of Changes
Other Study ID Numbers: 200802
Study First Received: January 20, 2009
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
Weight loss, urobilinogen

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014