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Completed

NCT Number: NCT04823598

Pushing and Manual Perineal Protection Techniques

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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Key information

Conditions

Perineal Tear Episiotomy Extended by Laceration Female Urogenital Diseases and Pregnancy Complications Labor Complication Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa Eğitim ve Araştırma Hastanesi

Istanbul, 34255, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Episiotomy

    Time frame: between the end of the second stage of labor and fetal expulsion

    Episiotomy rates

  2. Perineal lacerations

    Time frame: between the end of the second stage of labor and fetal expulsion

    Frequency of perineal lacerations according to their severity

Secondary outcomes

  1. Perineal pain

    Time frame: 24th hour after birth

    Average pain score obtained by the Visual Analog Scale

  2. Maternal birth satisfaction

    Time frame: 24th hour after birth

    Average score obtained by the Birth Satisfaction Scale

  3. Breastfeeding

    Time frame: 24th hour after birth

    Average score obtained by the Bristol Breastfeeding Assessment Tool

  4. Anal incontinence

    Time frame: 1th month after birth

    Mean anal incontinence score obtained by Wexner scale

  5. Pelvic muscle function

    Time frame: 1th month after birth

    Mean scores obtained by the "PERFECT scheme" regarding pelvic floor muscle function (total and subscale scores)

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2021
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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