Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Launched by UNIVERSITY OF CAMPANIA LUIGI VANVITELLI · Aug 9, 2025
Trial Information
Current as of August 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different ways to describe and classify second-degree vaginal tears that happen during natural childbirth. These tears involve the muscles around the vaginal opening but do not affect the muscles controlling the anus. While common, these tears can vary in how serious they are and may cause problems like pain, bleeding, hidden muscle injury, or issues with sexual function after delivery. The study aims to find out which classification system better predicts these complications, helping doctors give clearer advice and better care after childbirth.
Women who are 18 years or older, have a natural vaginal delivery, and experience a second-degree tear without any surgical cuts or tools used during delivery may be eligible to join. Participants will have their tear examined and classified using both systems as part of routine care, with no extra tests or treatments required. The study will then follow up to see how well each classification predicts things like pain, blood loss, hidden injuries seen on ultrasound, and sexual health after birth. The goal is to improve understanding and care for women who experience these tears during childbirth.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female at birth.
- • Age 18 years or older.
- • Spontaneous vaginal delivery
- • Presence of a spontaneous second-degree perineal tear, confirmed on postpartum examination.
- • Able and willing to provide informed consent to participate in the study.
- Exclusion Criteria:
- • Delivery involving episiotomy.
- • Operative vaginal delivery (forceps or vacuum).
- • Obstetric or medical conditions preventing spontaneous vaginal delivery.
- • Inability to understand study procedures or complete follow-up assessments.
About University Of Campania Luigi Vanvitelli
The University of Campania Luigi Vanvitelli is a distinguished academic institution located in Italy, renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive expertise in biomedical sciences to conduct innovative studies that address critical health challenges. With a focus on ethical standards and patient safety, the university collaborates with various healthcare professionals and research entities to facilitate groundbreaking clinical investigations, ultimately contributing to the development of new therapies and enhancing medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Naples, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported