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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04823598
Enrollment
164
Registered
2021-04-01
Start date
2021-04-21
Completion date
2023-05-25
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy Extended by Laceration, Labor Complication, Perineal Tear

Keywords

Episiotomy, Obstetric Labor Complications, Perineum

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.

Interventions

PROCEDURECoached 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.

PROCEDUREUncoached 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).

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Episiotomybetween the end of the second stage of labor and fetal expulsionEpisiotomy rates
Perineal lacerationsbetween the end of the second stage of labor and fetal expulsionFrequency of perineal lacerations according to their severity

Secondary

MeasureTime frameDescription
Breastfeeding24th hour after birthAverage score obtained by the Bristol Breastfeeding Assessment Tool
Perineal pain24th hour after birthAverage pain score obtained by the Visual Analog Scale
Pelvic muscle function1th month after birthMean scores obtained by the PERFECT scheme regarding pelvic floor muscle function (total and subscale scores)
Anal incontinence1th month after birthMean anal incontinence score obtained by Wexner scale
Maternal birth satisfaction24th hour after birthAverage score obtained by the Birth Satisfaction Scale

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026