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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00580879
Enrollment
80
Registered
2007-12-27
Start date
2005-01-31
Completion date
2009-03-31
Last updated
2010-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal Sphincter Laceration, Pelvic Floor Dysfunction

Keywords

Anorectal sphincter laceration, Pelvic floor dysfunction, Sphincter tear

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.6 Months

Secondary

MeasureTime frame
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.6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026