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Pushing and Manual Perineal Protection Techniques

I

Istinye University

Status

Completed

Conditions

Perineal Tear
Labor Complication
Episiotomy Extended by Laceration

Treatments

Procedure: Coached pushing and Finnish manual perineal protection
Procedure: Uncoached pushing and Hands-poised perineal protection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

164 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

164 participants in 2 patient groups

Reference group
Active Comparator group
Description:
Coached pushing and Finnish manual perineal protection
Treatment:
Procedure: Coached pushing and Finnish manual perineal protection
Study group
Experimental group
Description:
Uncoached pushing and Hands-poised perineal protection
Treatment:
Procedure: Uncoached pushing and Hands-poised perineal protection

Trial contacts and locations

1

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Central trial contact

Fatma Ketenci Gencer, Oby/Gyn; Refika Genç Koyucu, Assit.Prof.

Data sourced from clinicaltrials.gov

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