TerminatedNot Applicable

The Effect of Episiotomy on Maternal and Fetal Outcomes (EPITRIAL)

Stopped: Slower than expected recruitment rate, and larger than expected required sample.

Israel676 participantsStarted 2015-06

Plain-language summary

This study is aimed to evaluate the influence of episiotomy on various maternal and neonatal outcomes. Half of the participants will undergo selective episiotomy (according to routine delivery management at the particular hospital), while the other half will not undergo epitiotomy at all. Our hypothesis is that no differences in maternal and neonatal outcomes will be demonstrated between these two groups.

Who can participate

Age range

18 Years – 50 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: * Women in labor, or women scheduled for induction of labor, or women attending for a routine follow-up examination during third trimester of pregnancy. * First vaginal delivery * Singleton pregnancy above 34 gestational weeks * Vertex presentation * Women who are able to understand and sign the informed consent forms. Exclusion Criteria: Absolute contraindications for vaginal delivery (e.g. placenta previa, fetal macrosomia above 4.5 kg, genital herpes)

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

Obstetric Anal Sphincter injury

Timeframe: From the delivery to one hour after delivery

Trial details

NCT IDNCT02356237

SponsorLena Sagi-Dain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-06

View on ClinicalTrials.gov More Anal Sphincter Injury trials