Clinical trial NCT04823598: Pushing and Manual Perineal Protection Techniques
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Tear
Episiotomy Extended by Laceration
Labor Complication
Keywords: Episiotomy
Obstetric Labor Complications
Perineum
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Episiotomy
timeFrame: between the end of the second stage of labor and fetal expulsion
measure: Perineal lacerations
timeFrame: between the end of the second stage of labor and fetal expulsion
Secondary outcomes:
measure: Perineal pain
timeFrame: 24th hour after birth
measure: Maternal birth satisfaction
timeFrame: 24th hour after birth
measure: Breastfeeding
timeFrame: 24th hour after birth
measure: Anal incontinence
timeFrame: 1th month after birth
measure: Pelvic muscle function
timeFrame: 1th month after birth
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Eğitim ve Araştırma Hastanesi
Study officials:
References: