Pushing and Manual Perineal Protection Techniques

NCT04823598 | Completed

• 1 other identifier: HonHoP
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Tear; Episiotomy Extended by Laceration; Labor Complication

Keywords

Episiotomy; Obstetric Labor Complications; Perineum

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Perineal pain

  24th hour after birth

• Maternal birth satisfaction

  24th hour after birth

• Breastfeeding

  24th hour after birth

• Anal incontinence

  1th month after birth

• Pelvic muscle function

  1th month after birth

Study Arms (2)

Reference group

ACTIVE COMPARATOR

Coached pushing and Finnish manual perineal protection

Procedure: Coached pushing and Finnish manual perineal protection

Study group

EXPERIMENTAL

Uncoached pushing and Hands-poised perineal protection

Procedure: Uncoached pushing and Hands-poised perineal protection

Interventions

Coached pushing and Finnish manual perineal protection 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.

Reference group

Uncoached pushing and Hands-poised perineal protection 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).

Study group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Nulliparous pregnant women in the first stage of labor will be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparity
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Gaziosmanpaşa Eğitim ve Araştırma Hastanesi

Istanbul, 34255, Turkey (Türkiye)

Location

Related Publications (1)

• Genc Koyucu R, Ketenci Gencer F, Bilici SR. Effects of manual perineal protection and pushing techniques used in the second stage of labor on perineal outcomes: a randomized controlled trial of combinations of strategies. BMC Pregnancy Childbirth. 2025 Jun 19;25(1):671. doi: 10.1186/s12884-025-07564-6.

  PMID: 40537769 DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: April 21, 2021
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

TU (1)