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

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00580879
First received: December 20, 2007
Last updated: January 7, 2010
Last verified: January 2010
  Purpose

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.


Condition
Anorectal Sphincter Laceration
Pelvic Floor Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women in 36 weeks and upto 42 weeks of pregnancy

Criteria

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
  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: NCT00580879

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen L Noblett, M.D. University of California, Irvine
  More Information

No publications provided

Responsible Party: Karen Noblett, Associate Professor, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00580879     History of Changes
Other Study ID Numbers: 2005-4575
Study First Received: December 20, 2007
Last Updated: January 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Anorectal sphincter laceration
Pelvic floor dysfunction
Sphincter tear

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014