Perineal TearNCT04823598
Pushing and Manual Perineal Protection Techniques
A study testing Coached pushing and Finnish manual perineal protection and Uncoached pushing and Hands-poised perineal protection in people with Perineal Tear and Episiotomy Extended by Laceration, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Tear, Episiotomy Extended by Laceration, Labor Complication
- What is being tested?
- Coached pushing and Finnish manual perineal protection and Uncoached pushing and Hands-poised perineal protection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2021to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparity
- 37-40 weeks of gestation
- Singleton pregnancy
- Vertex presentation
- Risk-free pregnancy
- Estimated fetal weight 2500-4000 g
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- In the first stage of birth
- Amniotic membranes are intact
- Adequate knowledge of written and spoken Turkish
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Eğitim ve Araştırma Hastanesi
Istanbul, 34255
About this study
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
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.
- Being tested
- Coached pushing and Finnish manual perineal protection, Uncoached pushing and Hands-poised perineal protection
- Keywords
- Episiotomy, Obstetric Labor Complications, Perineum
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coached pushing and Finnish manual perineal protectionProcedure or surgery
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.
Uncoached pushing and Hands-poised perineal protectionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Active comparator | Coached pushing and Finnish manual perineal protection Receives: Procedure: Coached pushing and Finnish manual perineal protection |
| Study group | Experimental | Uncoached pushing and Hands-poised perineal protection Receives: Procedure: Uncoached pushing and Hands-poised perineal protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episiotomy
Episiotomy rates
Measured: between the end of the second stage of labor and fetal expulsion
Perineal lacerations
Frequency of perineal lacerations according to their severity
Measured: between the end of the second stage of labor and fetal expulsion
Secondary outcomes (5)
Perineal pain
Average pain score obtained by the Visual Analog Scale
Measured: 24th hour after birth
Maternal birth satisfaction
Average score obtained by the Birth Satisfaction Scale
Measured: 24th hour after birth
Breastfeeding
Average score obtained by the Bristol Breastfeeding Assessment Tool
Measured: 24th hour after birth
Anal incontinence
Mean anal incontinence score obtained by Wexner scale
Measured: 1th month after birth
Pelvic muscle function
Mean scores obtained by the "PERFECT scheme" regarding pelvic floor muscle function (total and subscale scores)
Measured: 1th month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start21 Apr 2021
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perineal TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Refika Genc Koyuncu, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823598
- Sponsor's protocol ID
- HonHoP
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Genc Koyucu R, Ketenci Gencer F, Bilici SR. Effects of manual perineal protection and pushing techniques used in the second stage of labor on perineal outcomes: a randomized controlled trial of combinations of strategies. BMC Pregnancy Childbirth. 2025 Jun 19;25(1):671. doi: 10.1186/s12884-025-07564-6.
PubMed 40537769
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04823598
- Acronym / sponsor ID
- HonHoP
- Keywords
- Episiotomy, Obstetric Labor Complications, Perineum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference group | Active comparator | Procedure: Coached pushing and Finnish manual perineal protectionCoached pushing and Finnish manual perineal protection |
| Study group | Experimental | Procedure: Uncoached pushing and Hands-poised perineal protectionUncoached pushing and Hands-poised perineal protection |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Nulliparity
- 37-40 weeks of gestation
- Singleton pregnancy
- Vertex presentation
- Risk-free pregnancy
Key exclusion criteria (13 listed)
- Cesarean delivery need
- Need for labor induction
- Need for operative delivery (vacuum, forceps)
- Need for obstetric analgesia
- Kristaller maneuver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coached pushing and Finnish manual perineal protectionPushing 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 or surgery | Reference group |
| Uncoached pushing and Hands-poised perineal protectionWomen 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). | Procedure or surgery | Study group |
Primary outcome
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
5 secondary outcomes
Perineal pain
Time frame: 24th hour after birth
Maternal birth satisfaction
Time frame: 24th hour after birth
Breastfeeding
Time frame: 24th hour after birth
Anal incontinence
Time frame: 1th month after birth
Pelvic muscle function
Time frame: 1th month after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 40537769Genc Koyucu R, Ketenci Gencer F, Bilici SR. Effects of manual perineal protection and pushing techniques used in the second stage of labor on perineal outcomes: a randomized controlled trial of combinations of strategies. BMC Pregnancy Childbirth. 2025 Jun 19;25(1):671. doi: 10.1186/s12884-025-07564-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coached pushing and Finnish manual perineal protection and Uncoached pushing and Hands-poised perineal protection in people with Perineal Tear and Episiotomy Extended by Laceration, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomy (time frame: between the end of the second stage of labor and fetal expulsion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.