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临床试验/NCT00826605
NCT00826605已完成不适用

Retrospective Investigation of Presence of Urobilinogen and Maternal Weight Loss as Indications of Impending Parturition in the Term Gravida

Oklahoma State University Center for Health Sciences2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Increase in urobilinogen on routine urine dipstick at prenatal appointment, term pregnancy

研究概览

简要总结

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?

详细描述

Rationale/Background:

This study is a retrospective review of records which examines the possibility of two markers for the onset of active labor (contractions which result in a change in the uterine cervical dilatation) on routine clinical prenatal assessment. The markers in question are an elevation of urobilinogen on routine dipstick and slight maternal weight loss. An apparent clinical correlation between the presence of urobilinogen, maternal weight loss and onset of active labor has been observed in our patient population. Our hypothesis is that these markers in the term gravida are an indication of delivery within a week of their appearance on routine prenatal evaluation. Should a correlation exist, the clinician would have a relatively inexpensive way of identifying patients that could deliver within the week and could possibly predict those patients that would have success with induction, as the normal labor process may have begun. 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 urobilinogen 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? In humans, the signals that initiate labor are not completely understood. While many theories have been explored, an exact pathway has not yet been determined. Urobilinogen is formed from conversion of conjugated bilirubin in the intestine by bacteria. A fraction of the urobiliogen is then reabsorbed into the bloodstream and filtered by the kidneys, becoming a colorless component of urine. Normally, only 1-4 mg of urobilinogen is excreted in the urine per day. Hemolytic processes, hepatocellular damage, and cholestasis can elevate urobilinogen in the urine. Routine dipstick tests have a normal urobilinogen range of 0.2 to 1 mg/dl (1). In this study, we will examine the urine dipsticks for an increased change in the urobilinogen levels within the last two prenatal appointments prior to delivery.

No previous studies could be located regarding a link between an elevation in urobilinogen and/or minor maternal weight loss and parturition, labor, onset. There have been studies to suggest rationale for our clinical observation, however. Estrogens and progesterone both play a role in the growth and contractility of uterine myometrial cells. Progesterone tends to promote uterine relaxation, hence the name "pro-gest...". In most species, progesterone levels dramatically fall, a 'withdrawal', prior to the onset of labor. However, in human and higher level primates, the progesterone and estrogen levels are both elevated in later gestation and during parturition. The "withdrawal" in humans, therefore, may be mediated by changes in the myometrial responsiveness to progesterone (2).

Estrogens induce myometrial contractility. Estriol is the most abundant estrogen during pregnancy and is produced by the placenta. It first appears at approximately the ninth week of gestation from the last menstrual period (3). Plasma concentrations of this estrogen increase throughout gestation along with those of estrone and estradiol (3,4,5). In the weeks preceding parturition, concentrations of estriol dramatically increase and continue to rise until birth (6). Estriol's roles include preparing uterine tissues for contraction and possibly signaling parturition in higher primates and humans (3,4,7,8,9,10). A rise in estriol, which can be monitored in saliva, has been shown to precede parturition, regardless of whether labor begins preterm, at term, or postterm (11,12).

Estrogens' effect on the liver has been studied extensively. The active transport of biliary components in the canaliculi is impaired by estrogen (13). The pregnant state can cause some changes in bile acid production and secretion, presumably due to the higher levels of estrogen, but also because of progesterone's effect on GI motility. This can lead to a mild subclinical cholestasis. Studies have shown conflicting evidence as to whether there is an increase in bile acid levels during pregnancy. As estrogen increases are known to induce a cholestasis, and urobilinogen levels increase in cholestasis, our hypothesis is that the increase in estrogen levels within the last week of pregnancy may slow the clearance of bile even further yielding the rise in urobilinogen levels noticed on routine dipstick.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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,
  • 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.

排除标准

  • 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).

结局指标

主要结局

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

时间窗: none--chart review

次要结局

  • Maternal weight loss at term before giving birth(none--chart review)

研究者

发起方
Oklahoma State University Center for Health Sciences
申办方类型
Other

研究点 (2)

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