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
About this trial
This is an interventional prevention trial for Perineal Tear focused on measuring Episiotomy, Obstetric Labor Complications, Perineum
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
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
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
Learn more about this trial
Pushing and Manual Perineal Protection Techniques
We'll reach out to this number within 24 hrs