Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study
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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 |
- 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 ]
- 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) |
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 |
Women in 36 weeks and upto 42 weeks of pregnancy
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| United States, California | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| 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 May 19, 2013