CompletedNot Applicable

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

United States80 participantsStarted 2005-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 6 Months

Trial details

NCT IDNCT00580879

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-03

View on ClinicalTrials.gov More Anorectal Sphincter Laceration trials