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 range18 Years – 50 Years

SexFEMALE

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)

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