Pushing and Manual Perineal Protection Techniques

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

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 Overview

• Status: Completed
• Conditions: Perineal Tear; Labor Complication; Episiotomy Extended by Laceration
• Intervention / Treatment: Procedure: Coached pushing and Finnish manual perineal protection; Procedure: Uncoached pushing and Hands-poised perineal protection

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34255
    • Gaziosmanpaşa Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference group; Coached pushing and Finnish manual perineal protection	Procedure: 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.
Experimental: Study group; Uncoached pushing and Hands-poised perineal protection	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 28, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Episiotomy; Obstetric Labor Complications; Perineum
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Lacerations
• Other Study ID Numbers: HonHoP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No