Pushing and Manual Perineal Protection Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2023-05-25

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.

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Detailed Description

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Conditions

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Perineal Tear Episiotomy Extended by Laceration Labor Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Reference group

Coached pushing and Finnish manual perineal protection

Group Type ACTIVE_COMPARATOR

Coached pushing and Finnish manual perineal protection

Intervention Type PROCEDURE

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.

Study group

Uncoached pushing and Hands-poised perineal protection

Group Type EXPERIMENTAL

Uncoached pushing and Hands-poised perineal protection

Intervention Type PROCEDURE

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).

Interventions

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Coached pushing and Finnish manual perineal protection

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.

Intervention Type PROCEDURE

Uncoached pushing and Hands-poised perineal protection

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).

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes