About this trial
The goal of this observational study is to learn whether different classification systems for second-degree perineal tears can predict postpartum complications in women undergoing spontaneous vaginal childbirth. The main questions it aims to answer are:
Does the Scandinavian classification better predict postpartum complications such as hemoglobin drop, perineal pain, occult muscle injury, and sexual dysfunction? Does the De Simone classification better correlate with these same postpartum outcomes?
Researchers will compare the Scandinavian classification and the De Simone classification to see which system more accurately predicts clinically relevant postpartum complications.
Participants will:
Undergo standard clinical assessment after spontaneous vaginal delivery with a second-degree perineal tear Have their perineal tear classified using both the Scandinavian and De Simone systems Receive routine postpartum evaluation, including hemoglobin measurement, pain assessment (VAS), and perineal ultrasound Complete follow-up assessment of sexual function using the Female Sexual Function Index (FSFI)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female at birth
Age ≥ 18 years
Spontaneous vaginal delivery
Presence of a spontaneous second-degree perineal tear confirmed on -postpartum examination
Disqualifiers
Obstetric or medical conditions preventing spontaneous vaginal delivery
Inability to understand study procedures or complete follow-up assessments
Trial population
Women giving birth, who experience a spontaneous vaginal delivery resulting in a spontaneous second-degree perineal tear. Participants are recruited consecutively from the hospital's maternity ward during the study period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
hemoglobin reduction
significant hemoglobin reduction (\>2 g/dL from pre- to post-delivery)
moderate-to-severe perineal pain
Visual Analog Scale (VAS) ≥ 5; (VAS; range 0-10, where 0 = no pain and 10 = worst imaginable pain); moderate-to-severe pain defined as VAS ≥ 5
pathological Female Sexual Function Index (FSFI) total score
FSFI total score modification after vaginal laceration Female Sexual Function Index (FSFI total score; range 2-36, where lower scores indicate worse sexual function and higher scores indicate better function), evaluated as change from baseline
Secondary outcomes
occult perineal or vaginal muscle lesions
occult perineal or vaginal muscle lesions on postpartum perineal ultrasound;
Sponsors and contacts
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