Pushing and Manual Perineal Protection Techniques

Labor Complication Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823598
• Other study ID #: HonHoP
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: April 2024
• Source: Istinye University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Episiotomy Extended by Laceration
• Labor Complication
• Lacerations
• Obstetric Labor Complications
• Perineal Tear

Intervention

Procedure:
• Coached pushing and Finnish manual perineal protection
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
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).

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episiotomy	Episiotomy rates	between the end of the second stage of labor and fetal expulsion
Primary	Perineal lacerations	Frequency of perineal lacerations according to their severity	between the end of the second stage of labor and fetal expulsion
Secondary	Perineal pain	Average pain score obtained by the Visual Analog Scale	24th hour after birth
Secondary	Maternal birth satisfaction	Average score obtained by the Birth Satisfaction Scale	24th hour after birth
Secondary	Breastfeeding	Average score obtained by the Bristol Breastfeeding Assessment Tool	24th hour after birth
Secondary	Anal incontinence	Mean anal incontinence score obtained by Wexner scale	1th month after birth
Secondary	Pelvic muscle function	Mean scores obtained by the "PERFECT scheme" regarding pelvic floor muscle function (total and subscale scores)	1th month after birth