PregnancyNCT06428812
The Effect of Perineal Protective Package Application on Pelvic Floor in Labor
A study testing Experimental: perineal package application group in people with Pregnancy and Labor, run by Öznur Hayat Öktem at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to… 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
- Pregnancy, Labor, Pelvic Floor
- What is being tested?
- Experimental: perineal package application group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2024to 11 Mar 2025
- 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
- 18- 35 years old
- Primipar
- Singleton pregnancy in the vertex position between 38 and 42 weeks
- A reactive NST tracing
- Without a systemic disease (heart, HT, diabetes)
- No problem speaking and understanding Turkish
- Who agreed to participate in the study
Who cannot join
- Obese pregnant women
- Pregnant women who gained more than 25 kilograms during pregnancy
- Multiple pregnancies
- Pregnant women with a neurological disease affecting the pelvic floor
- Pregnant women who have undergone pelvic surgery
- Contraindications for normal delivery (placenta previa, anomalies of presentation, etc.)
Show all 9Show fewer
- Estimated fetal weight of 4000 g or more
- Who wants to opt out of the study
- Pregnant women who are scheduled for cesarean section at any time of trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk Training and Research Hospital, obstetrics clinic
Karabük, 78100
About this study
Official title: Phd Student Msc Midwife
This study aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package; as a whole. The;perineal protective package; applications created by the researchers consisted of positioning on the gynecologic table (the back of the table was erected, the legs were removed from the hooks and placed on the sides of the table), open glottis pushing instead of closed glottis pushing, hot compress protection of the perineum instead of dry compress protection of the perineum, instead of lithotomy position in the second stage, which reduces the tension of the perineum and allows it to be observed and protected manually.
Read the detailed description
The pelvic floor plays a critical and important role in maintaining healthy functions of the urinary, genital and gastrointestinal systems. When tissues in a region of the pelvic floor are damaged for any reason, pelvic floor dysfunction develops.
Pregnancy and childbirth are important risk factors for pelvic floor dysfunction. Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function. During pregnancy, weight gain and increase in uterine weight increase intra-abdominal pressure. Therefore, ligaments and pelvic floor muscles are overstretched. He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger. During the passage and descent of the fetal head through the vaginal canal, the pelvic floor muscles can be overstretched, torn or damaged. Obstetric factors that cause pelvic floor damage include early or late age at first birth, high body mass index, large baby, length of the second stage of trauma (labor), forceps, vacuum, episiotomy and fundal compression.
Damage to the pelvic floor during labor has many short- and long-term effects on a woman\'s quality of life. These can be summarized as chronic perineal pain, pelvic organ prolapse, urinary and anal incontinence, fistula, sexual dysfunction, labor dissatisfaction, physical and psychological morbidities, and decreased quality of life. In addition, breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period. Therefore, it is important to prevent pelvic floor damage in childbirth, which negatively affects physical, social and psychological well-being and leads to many short and long-term morbidities. The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery.
In the literature, there are many studies examining interventions to protect the pelvic floor in labor. Studies show that perineal massage, perineal warm application, birth positions, hand maneuvers, pushing techniques, and limited episiotomy reduce the incidence of perineal injury.
However, studies on these techniques and practices are generally studies investigating the effectiveness of a single method. In a recent qualitative study, midwives were asked to evaluate the effect of some protective practices called; perineal package; as a whole. However, in this study, midwives; own practices and opinions were evaluated, and their effects on the pelvic floor or labor were not examined. International organizations recommend the application of evidence-based, perineal, and pelvic floor supportive and protective methods to pregnant women in labor. However, the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence, which are indicators of pelvic floor damage, is unclear and studies to evaluate this relationship are limited.
The research will be conducted in 4 stages. In Phase 1, pregnant women who meet the inclusion criteria will be interviewed when they are admitted to the delivery room. In the first interview, the relevant sections of the data collection form will be filled out, pelvic floor muscle strength will be measured with a perineometer, and the IIQ-7 and UDI-6 scales will be filled out. Pregnant women with incontinence detected in these scales will be excluded. Then, pregnant women will be randomized using the true random number generation method on the random.org website and assigned to the study and control groups. Then, the delivery process of all pregnant women in the study and control groups will be monitored and recorded using the relevant section of the data collection form.
In phase 2, the perineal pain felt by pregnant women in both groups will be evaluated using VAS when the second stage of labor begins. The second stage of labor is the time from complete dilatation of the cervix until the fetal head is born. During this stage, the study group will receive a perineal protection package while the control group will receive routine care. Postpartum perineal pain, episiotomy length if episiotomy was applied and perineal length will be measured in both groups. The results of the trauma will be recorded in the labor follow-up form.
In the 3rd stage, pregnant women in both groups will be interviewed at the 1st hour postpartum and perineal pain will be evaluated with VAS.
In the 4th stage, the pregnant women in the study and control groups will be measured pelvic muscle strength with a perineometer, perineal length will be measured and recorded on the relevant form during routine hospital control at the 6th week postpartum. UDI-6 (urinary distress inventory) and IIQ-7 (incontinence impact questionnaire) will be completed.
- Conditions
- Pregnancy, Labor, Pelvic Floor
- Being tested
- Experimental: perineal package application group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: perineal package application groupOther
This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made
| Study group | Role | What they receive |
|---|---|---|
| perineal package application group | Experimental | This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made Receives: Other: Experimental: perineal package application group |
| Routine hospital care | No intervention | Routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal muscle strengt
Perineal muscle strength will be measured in cmH2o with a perineometer.
Measured: On initial admission to the delivery room and after 6 weeks postpartum
Perineal Pain
Perineal pain will be assessed by VAS at the beginning and end of the second stage of labor and at the end of the 1st hour postpartum.
Measured: 1st hour postpartum
Secondary outcomes (2)
Episiotomy and laseration status
Episypotomy will be measured in cm with a paper ruler according to the application status.
Measured: 1st hour postpartum
Urinary incontinence status
Urinary incontinence status will be measured with UDI-6 and IIQ-7.
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start8 Jul 2024
- Primary completion11 Mar 2025
- Study completion11 Mar 2025
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 PregnancyStudies 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
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Öznur Hayat Öktem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Öznur Hayat Öktem, Gulhane School of Medicine
- Investigators
- Nazan KARAHAN, Associate professor, Study director, Gulhane School of MedicineMEHMET BÜLBÜL, Associate professor, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428812
- Sponsor's protocol ID
- Hayatoktem02
- Status last verified
- Jun 2025
- First submitted
- 15 May 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
undefined
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phd Student Msc Midwife
- ClinicalTrials.gov ID
- NCT06428812
- Acronym / sponsor ID
- Hayatoktem02
- Conditions
- Pregnancy, Labor, Pelvic Floor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Öznur Hayat ÖktemUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 24 May 2024 (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.
This study aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package; as a whole. The;perineal protective package; applications created by the researchers consisted of positioning on the gynecologic table (the back of the table was erected, the legs were removed from the hooks and placed on the sides of the table), open glottis pushing instead of closed glottis pushing, hot compress protection of the perineum instead of dry compress protection of the perineum, instead of lithotomy position in the second stage, which reduces the tension of the perineum and allows it to be observed and protected manually.
Detailed description
The pelvic floor plays a critical and important role in maintaining healthy functions of the urinary, genital and gastrointestinal systems. When tissues in a region of the pelvic floor are damaged for any reason, pelvic floor dysfunction develops.
Pregnancy and childbirth are important risk factors for pelvic floor dysfunction. Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function. During pregnancy, weight gain and increase in uterine weight increase intra-abdominal pressure. Therefore, ligaments and pelvic floor muscles are overstretched. He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger. During the passage and descent of the fetal head through the vaginal canal, the pelvic floor muscles can be overstretched, torn or damaged. Obstetric factors that cause pelvic floor damage include early or late age at first birth, high body mass index, large baby, length of the second stage of trauma (labor), forceps, vacuum, episiotomy and fundal compression.
Damage to the pelvic floor during labor has many short- and long-term effects on a woman\'s quality of life. These can be summarized as chronic perineal pain, pelvic organ prolapse, urinary and anal incontinence, fistula, sexual dysfunction, labor dissatisfaction, physical and psychological morbidities, and decreased quality of life. In addition, breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period. Therefore, it is important to prevent pelvic floor damage in childbirth, which negatively affects physical, social and psychological well-being and leads to many short and long-term morbidities. The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery.
In the literature, there are many studies examining interventions to protect the pelvic floor in labor. Studies show that perineal massage, perineal warm application, birth positions, hand maneuvers, pushing techniques, and limited episiotomy reduce the incidence of perineal injury.
However, studies on these techniques and practices are generally studies investigating the effectiveness of a single method. In a recent qualitative study, midwives were asked to evaluate the effect of some protective practices called; perineal package; as a whole. However, in this study, midwives; own practices and opinions were evaluated, and their effects on the pelvic floor or labor were not examined. International organizations recommend the application of evidence-based, perineal, and pelvic floor supportive and protective methods to pregnant women in labor. However, the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence, which are indicators of pelvic floor damage, is unclear and studies to evaluate this relationship are limited.
The research will be conducted in 4 stages. In Phase 1, pregnant women who meet the inclusion criteria will be interviewed when they are admitted to the delivery room. In the first interview, the relevant sections of the data collection form will be filled out, pelvic floor muscle strength will be measured with a perineometer, and the IIQ-7 and UDI-6 scales will be filled out. Pregnant women with incontinence detected in these scales will be excluded. Then, pregnant women will be randomized using the true random number generation method on the random.org website and assigned to the study and control groups. Then, the delivery process of all pregnant women in the study and control groups will be monitored and recorded using the relevant section of the data collection form.
In phase 2, the perineal pain felt by pregnant women in both groups will be evaluated using VAS when the second stage of labor begins. The second stage of labor is the time from complete dilatation of the cervix until the fetal head is born. During this stage, the study group will receive a perineal protection package while the control group will receive routine care. Postpartum perineal pain, episiotomy length if episiotomy was applied and perineal length will be measured in both groups. The results of the trauma will be recorded in the labor follow-up form.
In the 3rd stage, pregnant women in both groups will be interviewed at the 1st hour postpartum and perineal pain will be evaluated with VAS.
In the 4th stage, the pregnant women in the study and control groups will be measured pelvic muscle strength with a perineometer, perineal length will be measured and recorded on the relevant form during routine hospital control at the 6th week postpartum. UDI-6 (urinary distress inventory) and IIQ-7 (incontinence impact questionnaire) will be completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineal package application group | Experimental | Other: Experimental: perineal package application groupThis group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made |
| Routine hospital care | No intervention | –Routine hospital care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18- 35 years old
- Primipar
- Singleton pregnancy in the vertex position between 38 and 42 weeks
- A reactive NST tracing
- Without a systemic disease (heart, HT, diabetes)
Key exclusion criteria (9 listed)
- Obese pregnant women
- Pregnant women who gained more than 25 kilograms during pregnancy
- Multiple pregnancies
- Pregnant women with a neurological disease affecting the pelvic floor
- Pregnant women who have undergone pelvic surgery
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 |
|---|---|---|
| Experimental: perineal package application groupThis group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made | Other | perineal package application group |
Primary outcome
Perineal muscle strengt
Time frame: On initial admission to the delivery room and after 6 weeks postpartum
Perineal muscle strength will be measured in cmH2o with a perineometer.
Perineal Pain
Time frame: 1st hour postpartum
Perineal pain will be assessed by VAS at the beginning and end of the second stage of labor and at the end of the 1st hour postpartum.
2 secondary outcomes
Episiotomy and laseration status
Time frame: 1st hour postpartum
Urinary incontinence status
Time frame: 6 weeks postpartum
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 17 Jun 2025.
- Backgroundundefined
- Individual participant dataSharing planned: No
Related trials for Pregnancy
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
RecruitingObservational study
Glucose Levels and Outcomes in Women - Mid Pregnancy
Pregnancy
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
Nazan KARAHAN, Associate professor study director
Gulhane School of Medicine
MEHMET BÜLBÜL, Associate professor principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: perineal package application group in people with Pregnancy and Labor, run by Öznur Hayat Öktem 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 7 inclusion and 9 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 17 Jun 2025. 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?
Perineal muscle strengt (time frame: On initial admission to the delivery room and after 6 weeks postpartum). 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 NCT06428812, 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 17 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.