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Effect of an Evidence-Based Care Program on the Prevention of Perineal Birth Trauma

The Effect of Implementing an Evidence-Based Care Program to Prevent Perineal Trauma During Labor and Delivery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241106063624N1
Enrollment
232
Registered
2024-12-05
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal laceration during delivery. Perineal laceration during delivery

Interventions

Intervention 1: Intervention group: In this study, the intervention group will implement a program designed based on a review of the literature and current global evidence on preventing perineal birth

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Live Singleton pregnancy, BMI=30, Gestational age 37 to 41 weeks (based on the LMP or first-trimester sonography), Cephalic presentation, Normal fetal heart rate (110-160), and Reactive NST, Primi para or second para.

Exclusion criteria

Exclusion criteria: Diagnosis of abnormal dimensions of the pelvis through vaginal examination, Abnormal vaginal bleeding, regional anesthesia, The presence of any abnormalities in the soft or bony tissue of the birth canal or the position of the fetus (severe asynclitism and stable posterior occiput), IUGR, History of any uterine scar. EFW>4000 gr or EFW<2500 gr, Indication for cesarean section Rupture of fetal membranes more than 18 hours High-risk pregnancy (preeclampsia, placenta previa, decollement, chorioamnionitis, placenta accreta, placenta previa).

Design outcomes

Primary

MeasureTime frame
The rate of spontaneous tears of the perineum. Timepoint: The fourth stage of labor after the placenta expelled. Method of measurement: Classification of perineal tears based on the Sultan system and according to the observation form.;The rate of episiotomy. Timepoint: The fourth stage of labor after the placenta expelled. Method of measurement: According to the observation form.

Secondary

MeasureTime frame
Neonatal admission rate. Timepoint: 2 hours after birth. Method of measurement: Based on the information in the mother's file.;Apgar score at 1 min. Timepoint: The third stage of labor. Method of measurement: Based on the Apgar scoring system for newborns after birth.;Time to start breastfeeding a newborn. Timepoint: Fourth stage of labor. Method of measurement: Based on the observation form.;Duration of the second stage of labor. Timepoint: Fourth stage of labor. Method of measurement: Based on the information of the mother's file.;Amount of bleeding. Timepoint: 8 hours after delivery. Method of measurement: Measurement of hemoglobin and hematocrit changes upon mothers' admission and re-evaluation 8 hours after delivery.;The level of perineal pain. Timepoint: The first 24 hours and 2 weeks after childbirth. Method of measurement: Visual Analogue Scale.;Mothers' childbirth experience. Timepoint: 2 weeks after childbirth. Method of measurement: Childbirth Experience Questionnaire(CEQ).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Abbaspoor

Ahvaz University of Medical Sciences

abbaspoor-z@ajums.ac.ir+98 916 615 2841

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026