Comparing Spontaneous Versus Interventionist Approaches: A Randomized Controlled Study on the Impact of Manual Perineal Protection and Pushing Techniques on Perineal Outcomes in Nulliparous Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istinye University
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- Episiotomy
Study Overview
Brief Summary
Perineal trauma during vaginal delivery is very common, especially in countries with a high prevalence of episiotomy. Perineal traumas can range from tears limited to the skin, subcutaneous and vaginal mucosa to severe tears involving the anal sphincter and rectal mucosa. Perineal trauma is associated with short-term morbidities such as bleeding, infection, pain, edema. Besides, it may cause long-term morbidities such as urinary incontinence, fecal incontinence, dyspareunia, a decrease in quality of life, a need for surgery, and psychosocial problems. Moreover, it is associated with an increase in national healthcare costs and malpractice cases. For these reasons, some measures to reduce the frequency of perineal trauma have been discussed for many years. Pushing techniques applied in the second stage of labor and manual perineum protection techniques applied during fetal expulsion are among these. Current data are insufficient to make definitive recommendations. In this study, it was aimed to compare different pushing and perineal protection techniques in the second stage of labor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Nulliparity
- •37-40 weeks of gestation
- •Singleton pregnancy
- •Vertex presentation
- •Risk-free pregnancy
- •Estimated fetal weight 2500-4000 g
- •In the first stage of birth
- •Amniotic membranes are intact
- •Adequate knowledge of written and spoken Turkish
Exclusion Criteria
- •Cesarean delivery need
- •Need for labor induction
- •Need for operative delivery (vacuum, forceps)
- •Need for obstetric analgesia
- •Kristaller maneuver
- •Perineal preparation during pregnancy (perineal massage in the last month of pregnancy, etc.)
- •Vulvo-vaginal infection
- •Vulvar severe varicose veins
- •Postpartum atony
- •Non-compliance with research follow-up criteria
- •Covid-19 positivity
- •Non-compliance with the procedure of the group involved
- •Neuropsychiatric and other diseases that cause understanding, speech, and expression disorders
Outcomes
Primary Outcomes
Episiotomy
Time Frame: between the end of the second stage of labor and fetal expulsion
Episiotomy rates
Perineal lacerations
Time Frame: between the end of the second stage of labor and fetal expulsion
Frequency of perineal lacerations according to their severity
Secondary Outcomes
- Perineal pain(24th hour after birth)
- Breastfeeding(24th hour after birth)
- Pelvic muscle function(1th month after birth)
- Maternal birth satisfaction(24th hour after birth)
- Anal incontinence(1th month after birth)
Investigators
Refika Genc Koyuncu
assistant professor
Istinye University