Pushing and Manual Perineal Protection Techniques

Not Applicable

Completed

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

• Registration Number: NCT04823598
• Lead Sponsor: Istinye University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-28
• Study First Posted: 2021-04-01
• Study Start: 2021-04-21
• Primary Completion: 2023-05-25
• Study Completion: 2023-05-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-20
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Uncoached pushing and Hands-poised perineal protection	Uncoached pushing and Hands-poised perineal protection
Reference group	Coached pushing and Finnish manual perineal protection	Coached pushing and Finnish manual perineal protection

Primary Outcome Measures

Name	Time	Method
Episiotomy	between the end of the second stage of labor and fetal expulsion	Episiotomy rates
Perineal lacerations	between the end of the second stage of labor and fetal expulsion	Frequency of perineal lacerations according to their severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gaziosmanpaşa Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey