An interventional study of Coached pushing and Finnish manual perineal protection and Uncoached pushing and Hands-poised perineal protection in Perineal Tear, Episiotomy Extended by Laceration and Labor Complication, sponsored by Istinye University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Istinye University · Not applicable, Interventional, and Prevention
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.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's enrollment of 164 is close to the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
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Coached pushing and Finnish manual perineal protection
Procedure: Coached pushing and Finnish manual perineal protection
Uncoached pushing and Hands-poised perineal protection
Procedure: Uncoached pushing and Hands-poised 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.
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).
Episiotomy
Episiotomy rates
Time frame: between the end of the second stage of labor and fetal expulsion
Perineal lacerations
Frequency of perineal lacerations according to their severity
Time frame: between the end of the second stage of labor and fetal expulsion
Perineal pain
Average pain score obtained by the Visual Analog Scale
Time frame: 24th hour after birth
Maternal birth satisfaction
Average score obtained by the Birth Satisfaction Scale
Time frame: 24th hour after birth
Breastfeeding
Average score obtained by the Bristol Breastfeeding Assessment Tool
Time frame: 24th hour after birth
Anal incontinence
Mean anal incontinence score obtained by Wexner scale
Time frame: 1th month after birth
Pelvic muscle function
Mean scores obtained by the "PERFECT scheme" regarding pelvic floor muscle function (total and subscale scores)
Time frame: 1th month after birth
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in May 2023, 25 months.
Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's 25 months is below that.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Obstetric Labor Complications →