NCT04823598

Pushing and Manual Perineal Protection Techniques

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Istinye University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Perineal Tear
• Episiotomy Extended by Laceration
• Labor Complication

Interventions

Type	Name	Description
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.
PROCEDURE	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).

Timeline

• Start date: 2021-04-21
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2021-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: Turkey (Türkiye)