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Completed

NCT Number: NCT00580879

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, Irvine Medical Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 27, 2007
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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