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Pushing and Manual Perineal Protection Techniques

Primary Purpose

Perineal Tear, Episiotomy Extended by Laceration, Labor Complication

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coached pushing and Finnish manual perineal protection
Uncoached pushing and Hands-poised perineal protection
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perineal Tear focused on measuring Episiotomy, Obstetric Labor Complications, Perineum

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Reference group

    Study group

    Arm Description

    Coached pushing and Finnish manual perineal protection

    Uncoached pushing and Hands-poised perineal protection

    Outcomes

    Primary Outcome Measures

    Episiotomy
    Episiotomy rates
    Perineal lacerations
    Frequency of perineal lacerations according to their severity

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 25, 2021
    Last Updated
    March 28, 2021
    Sponsor
    Istinye University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04823598
    Brief Title
    Pushing and Manual Perineal Protection Techniques
    Official Title
    The Effects of Pushing and Manual Perineal Protection Techniques on Perineal Outcomes: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istinye University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Perineal Tear, Episiotomy Extended by Laceration, Labor Complication
    Keywords
    Episiotomy, Obstetric Labor Complications, Perineum

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Reference group
    Arm Type
    Active Comparator
    Arm Description
    Coached pushing and Finnish manual perineal protection
    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Uncoached pushing and Hands-poised perineal protection
    Intervention Type
    Procedure
    Intervention Name(s)
    Coached pushing and Finnish manual perineal protection
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Uncoached pushing and Hands-poised perineal protection
    Intervention Description
    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 Outcome Measure Information:
    Title
    Episiotomy
    Description
    Episiotomy rates
    Time Frame
    between the end of the second stage of labor and fetal expulsion
    Title
    Perineal lacerations
    Description
    Frequency of perineal lacerations according to their severity
    Time Frame
    between the end of the second stage of labor and fetal expulsion
    Secondary Outcome Measure Information:
    Title
    Perineal pain
    Description
    Average pain score obtained by the Visual Analog Scale
    Time Frame
    24th hour after birth
    Title
    Maternal birth satisfaction
    Description
    Average score obtained by the Birth Satisfaction Scale
    Time Frame
    24th hour after birth
    Title
    Breastfeeding
    Description
    Average score obtained by the Bristol Breastfeeding Assessment Tool
    Time Frame
    24th hour after birth
    Title
    Anal incontinence
    Description
    Mean anal incontinence score obtained by Wexner scale
    Time Frame
    1th month after birth
    Title
    Pelvic muscle function
    Description
    Mean scores obtained by the "PERFECT scheme" regarding pelvic floor muscle function (total and subscale scores)
    Time Frame
    1th month after birth

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Nulliparous pregnant women in the first stage of labor will be included in the study.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Refika Genç Koyucu, Assit.Prof.
    Phone
    +905303149679
    Email
    refika_genc@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma Ketenci Gencer, Oby/Gyn
    Phone
    +90 541 6116469
    Email
    fathma_k@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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