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Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00580879
First Posted: December 27, 2007
Last Update Posted: January 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Irvine
December 20, 2007
December 27, 2007
January 11, 2010
January 2005
March 2009   (Final data collection date for primary outcome measure)
Fetal head circumference and position, maternal pelvis, infant weight, maternal weight, length of the second stage, the incidence of sphincter tears as diagnosed by transvaginal ultrasound as well as the incidence of fecal urgency and incontinence. [ Time Frame: 6 Months ]
Same as current
Complete list of historical versions of study NCT00580879 on ClinicalTrials.gov Archive Site
The magnitude of the effect of other factors such as maternal obesity, maternal age, duration of labor and pelvimetry on the risk of anorectal lacerations will be examined. [ Time Frame: 6 Months ]
The magnitude of the effect of other factors such as maternal obesity, maternal age, duration of labor and pelvimetry on the risk of anoretal lacerations will be examined. [ Time Frame: 6 Months ]
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Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study
Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study
The purpose of this study is to see if fetal head circumference can be used as a predictor for who will experience a sphincter laceration while delivering.
Even though much work has been invested in trying to identify risk factors that can predict which population will suffer from sphincter tears and other pelvic floor trauma, the epidemiology is still poorly understood. Factors that have been implicated to include operative vaginal delivery, birth weight, and primaparity. Up to this point little focus has been placed on antenatal factors that would help predict and prevent sphincter disruptions. At the time of birth the infant's head is the largest part of the body. Thus, head circumference of the infant may be able to predict which subjects is more likely to suffer from sphincter disruption. Thus, this study aims to determine whether or not fetal head circumference measured antenatally is predictive of pelvic floor trauma.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Women in 36 weeks and upto 42 weeks of pregnancy
  • Anorectal Sphincter Laceration
  • Pelvic Floor Dysfunction
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primiparous subjects at least 18 years of age
  • Gestational age greater than or equal to 36 weeks and upto 42 weeks gestation
  • Subjects must have give written informed consent to participate in this study
  • Subjects must be planning to deliver at UCI

Exclusion Criteria:

  • Subjects less than 18 years of age
  • Subjects with a previous delivery
  • Subjects with previous colorectal surgery or hemorrhoidal surgery
  • Subjects with a history of irritable bowel syndrome, ulcerative colitis, or Crohn's disease
  • Subjects with a history of colon or rectal cancer
  • Gestational age less than 36 weeks
  • Cesarean section
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00580879
2005-4575
Yes
Not Provided
Not Provided
Karen Noblett, Associate Professor, University of California, Irvine Medical Center
University of California, Irvine
Not Provided
Principal Investigator: Karen L Noblett, M.D. University of California, Irvine
University of California, Irvine
January 2010