Pushing and Manual Perineal Protection Techniques
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| ClinicalTrials.gov Identifier: NCT04823598 |
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Recruitment Status :
Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
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Sponsor:
Istinye University
Information provided by (Responsible Party):
Refika Genc Koyuncu, Istinye University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perineal Tear Episiotomy Extended by Laceration Labor Complication | Procedure: Coached pushing and Finnish manual perineal protection Procedure: Uncoached pushing and Hands-poised perineal protection | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Care Provider) |
| Primary Purpose: | Prevention |
| Official Title: | The Effects of Pushing and Manual Perineal Protection Techniques on Perineal Outcomes: A Randomized Controlled Study |
| Estimated Study Start Date : | April 2021 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | May 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Reference group
Coached pushing and Finnish manual perineal protection
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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. |
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Experimental: Study group
Uncoached pushing and Hands-poised perineal protection
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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). |
Primary Outcome Measures :
- Episiotomy [ Time Frame: between the end of the second stage of labor and fetal expulsion ]Episiotomy rates
- Perineal lacerations [ Time Frame: between the end of the second stage of labor and fetal expulsion ]Frequency of perineal lacerations according to their severity
Secondary Outcome Measures :
- Perineal pain [ Time Frame: 24th hour after birth ]Average pain score obtained by the Visual Analog Scale
- Maternal birth satisfaction [ Time Frame: 24th hour after birth ]Average score obtained by the Birth Satisfaction Scale
- Breastfeeding [ Time Frame: 24th hour after birth ]Average score obtained by the Bristol Breastfeeding Assessment Tool
- Anal incontinence [ Time Frame: 1th month after birth ]Mean anal incontinence score obtained by Wexner scale
- Pelvic muscle function [ Time Frame: 1th month after birth ]Mean scores obtained by the "PERFECT scheme" regarding pelvic floor muscle function (total and subscale scores)
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| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Nulliparous pregnant women in the first stage of labor will be included in the study. |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823598
Contacts
| Contact: Refika Genç Koyucu, Assit.Prof. | +905303149679 | refika_genc@hotmail.com | |
| Contact: Fatma Ketenci Gencer, Oby/Gyn | +90 541 6116469 | fathma_k@hotmail.com |
Sponsors and Collaborators
Istinye University
| Responsible Party: | Refika Genc Koyuncu, assistant professor, Istinye University |
| ClinicalTrials.gov Identifier: | NCT04823598 |
| Other Study ID Numbers: |
HonHoP |
| First Posted: | April 1, 2021 Key Record Dates |
| Last Update Posted: | April 1, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Refika Genc Koyuncu, Istinye University:
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Episiotomy Obstetric Labor Complications Perineum |
Additional relevant MeSH terms:
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Obstetric Labor Complications Lacerations Wounds and Injuries Pregnancy Complications |