Pushing and Manual Perineal Protection Techniques

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Pushing and Manual Perineal Protection Techniques on Perineal Outcomes: A Randomized Controlled Study

Conditions
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Perineal Tear, Episiotomy Extended by Laceration, Labor Complication

Intervention / Treatment
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* Procedure: Coached pushing and Finnish manual perineal protection
* Procedure: Uncoached pushing and Hands-poised perineal protection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference group<br>Coached pushing and Finnish manual perineal protection | Procedure: Coached pushing and Finnish manual perineal protection<br>* Pushing technique: Rest will be encouraged between uterine contractions. With the onset of uterine contraction, women will be instructed to breathe normally. They will then be instructed to take a deep breath and hold (closed-glottis), and push down strongly for as long as possible (up to 10 seconds). After pushing effort, normal breathing will be encouraged, then the same pushing instruction will be repeated again. Fetal expulsion: The expulsion rate of the fetal head will be controlled by light pressure applied on the fetal occiput. Simultaneously, the thumb and index finger of the dominant hand will be used to support the perineum, while the bent middle finger will grasp the baby's chin. Once a good grip is achieved, the investigator slowly assists in the expulsion of the fetal head from the vaginal introitus. When most of the fetal head is out, the perineal ring will be pushed under the baby's chin.<br>|
| Experimental: Study group<br>Uncoached pushing and Hands-poised perineal protection | Procedure: Uncoached pushing and Hands-poised perineal protection<br>* Women will not be given any instructions regarding straining and breathing, and will be allowed to follow their own pushing impulses. During the expulsion of the fetal head, the hands of the researcher will be kept in the air and ready for the intervention, but pressure will not be applied to the fetal head or perineum unless necessary (fetal hypoxic appearance, strain detection with a risk of spontaneous laceration towards the anus in the midline).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episiotomy | Episiotomy rates | between the end of the second stage of labor and fetal expulsion | 
| Perineal lacerations | Frequency of perineal lacerations according to their severity | between the end of the second stage of labor and fetal expulsion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perineal pain | Average pain score obtained by the Visual Analog Scale | 24th hour after birth | 
| Maternal birth satisfaction | Average score obtained by the Birth Satisfaction Scale | 24th hour after birth | 
| Breastfeeding | Average score obtained by the Bristol Breastfeeding Assessment Tool | 24th hour after birth | 
| Anal incontinence | Mean anal incontinence score obtained by Wexner scale | 1th month after birth | 
| Pelvic muscle function | Mean scores obtained by the PERFECT scheme regarding pelvic floor muscle function (total and subscale scores) | 1th month after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episiotomy, Obstetric Labor Complications, Perineum