NCT00826605

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2010

Enrollment Period

6 months

First QC Date

January 20, 2009

Last Update Submit

January 26, 2010

Conditions

Keywords

Weight loss, urobilinogen

Outcome Measures

Primary Outcomes (1)

  • Increase in urobilinogen on routine urine dipstick at prenatal appointment, term pregnancy

    none--chart review

Secondary Outcomes (1)

  • Maternal weight loss at term before giving birth

    none--chart review

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OSU Houston Center OB/Gyn Clinic

Tulsa, Oklahoma, 74127, United States

Location

OSU Medical Center

Tulsa, Oklahoma, 74127, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Harris, DO

    OSU Center for Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

January 28, 2010

Record last verified: 2010-01

Locations