Perineal TraumaNCT07713173
Ritgen Maneuver and Birth-Related Perineal Trauma: RCT
A study testing Ritgen maneuver and Routine Care Group in people with Perineal Trauma and Ritgen Maneuver, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Perineal trauma is one of the common complications that may occur during the second stage of labor and can negatively affect women's postpartum recovery and quality of life. The Ritgen maneuver is a hands-on perineal protection technique performed during fetal head delivery to control the birth of the fetal head and… Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Trauma, Ritgen Maneuver
- What is being tested?
- Ritgen maneuver and Routine Care Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2025to 26 May 2026
- 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 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 20 years or older.
- Gestational age ≥37 weeks.
- Singleton pregnancy.
- Cephalic (vertex) presentation.
- Planned vaginal birth.
- No perineal massage during the last 4 weeks of pregnancy.
- Not regularly engaged in active sports activity.
- Willing to participate and provide informed consent
Who cannot join
- Fetal anomaly.
- Human papillomavirus (HPV) infection.
- Herpes simplex virus (HSV) infection.
- Presence of perineal edema.
- Vulvar varicosities.
- Opioid administration during labor.
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- Prolonged labor.
- Labor dystocia.
- Development of fetal distress during labor.
- Instrumental vaginal delivery (vacuum, Kiwi, or forceps-assisted delivery)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Esenler Maternity and Pediatric Hospital
Istanbul
About this study
Official title: The Effect of the Ritgen Maneuver on Perineal Trauma During the Second Stage of Labor: A Randomized Controlled Trial
Perineal trauma is one of the common complications that may occur during the second stage of labor and can negatively affect women's postpartum recovery and quality of life. The Ritgen maneuver is a hands-on perineal protection technique performed during fetal head delivery to control the birth of the fetal head and potentially reduce perineal injury. However, evidence regarding its effectiveness remains inconsistent.
This randomized controlled trial aims to evaluate the effect of the Ritgen maneuver on perineal trauma during the second stage of labor. Pregnant women admitted for vaginal birth will be randomly assigned to either the Ritgen maneuver group or the standard care group. The incidence and degree of perineal trauma, episiotomy, and related maternal outcomes will be compared between groups.
The findings of this study are expected to contribute to the evidence base regarding perineal protection techniques during vaginal birth and support the development of clinical practices aimed at reducing birth-related perineal trauma
- Conditions
- Perineal Trauma, Ritgen Maneuver
- Being tested
- Ritgen maneuver, Routine Care Group
- Keywords
- ritgen maneuver, perineal trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritgen maneuverOther
The Ritgen maneuver was performed during crowning and delivery of the fetal head. One hand was used to control the fetal head while the other supported the perineum to facilitate controlled birth and potentially reduce perineal injury
Routine Care GroupOther
Standard management of the second stage of labor according to institutional practice without application of the Ritgen maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Ritgen Maneuver Group | Experimental | Participants in this group received the Ritgen maneuver during the second stage of labor. The maneuver was applied during delivery of the fetal head with the aim of protecting the perineum and reducing perineal trauma. Perineal outcomes were assessed following birth Receives: Other: Ritgen maneuver |
| Routine Care Group | Other | Participants in this group received routine intrapartum care during the second stage of labor according to institutional practice without application of the Ritgen maneuver. Perineal outcomes were assessed following birth. Receives: Other: Routine Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Perineal Trauma
The occurrence of any perineal trauma following vaginal birth, including spontaneous perineal lacerations and episiotomy-related perineal injury.
Measured: Immediately after birth
Secondary outcomes (1)
Postpartum Pain Score
Maternal postpartum pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Within 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start9 Sep 2025
- Primary completion26 May 2026
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perineal TraumaStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants were randomly assigned to either a Ritgen maneuver group or a control group receiving routine care during the second stage of labor. Perineal trauma outcomes were compared between groups.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Küğcümen, Medipol University
- Investigators
- Gozde Kugcumen, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713173
- Sponsor's protocol ID
- E-10840098-202.3.02-3487
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmadi Z, Torkzahrani S, Roosta F, Shakeri N, Mhmoodi Z. Effect of Breathing Technique of Blowing on the Extent of Damage to the Perineum at the Moment of Delivery: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2017 Jan-Feb;22(1):62-66. doi: 10.4103/1735-9066.202071.
PubMed 28382061Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens Health. 2005 Sep-Oct;50(5):365-72. doi: 10.1016/j.jmwh.2005.05.012.
PubMed 16154062
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Ritgen Maneuver on Perineal Trauma During the Second Stage of Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07713173
- Acronym / sponsor ID
- E-10840098-202.3.02-3487
- Conditions
- Perineal Trauma, Ritgen Maneuver
- Keywords
- ritgen maneuver, perineal trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 26 May 2026 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 20 Jul 2026 (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 is one of the common complications that may occur during the second stage of labor and can negatively affect women's postpartum recovery and quality of life. The Ritgen maneuver is a hands-on perineal protection technique performed during fetal head delivery to control the birth of the fetal head and potentially reduce perineal injury. However, evidence regarding its effectiveness remains inconsistent.
This randomized controlled trial aims to evaluate the effect of the Ritgen maneuver on perineal trauma during the second stage of labor. Pregnant women admitted for vaginal birth will be randomly assigned to either the Ritgen maneuver group or the standard care group. The incidence and degree of perineal trauma, episiotomy, and related maternal outcomes will be compared between groups.
The findings of this study are expected to contribute to the evidence base regarding perineal protection techniques during vaginal birth and support the development of clinical practices aimed at reducing birth-related perineal trauma
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either a Ritgen maneuver group or a control group receiving routine care during the second stage of labor. Perineal trauma outcomes were compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Ritgen Maneuver Group | Experimental | Other: Ritgen maneuverParticipants in this group received the Ritgen maneuver during the second stage of labor. The maneuver was applied during delivery of the fetal head with the aim of protecting the perineum and reducing perineal trauma. Perineal outcomes were assessed following birth |
| Routine Care Group | Other | Other: Routine Care GroupParticipants in this group received routine intrapartum care during the second stage of labor according to institutional practice without application of the Ritgen maneuver. Perineal outcomes were assessed following birth. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant women aged 20 years or older.
- Gestational age ≥37 weeks.
- Singleton pregnancy.
- Cephalic (vertex) presentation.
- Planned vaginal birth.
Key exclusion criteria (10 listed)
- Fetal anomaly.
- Human papillomavirus (HPV) infection.
- Herpes simplex virus (HSV) infection.
- Presence of perineal edema.
- Vulvar varicosities.
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 |
|---|---|---|
| Ritgen maneuverThe Ritgen maneuver was performed during crowning and delivery of the fetal head. One hand was used to control the fetal head while the other supported the perineum to facilitate controlled birth and potentially reduce perineal injury | Other | Ritgen Maneuver Group |
| Routine Care GroupStandard management of the second stage of labor according to institutional practice without application of the Ritgen maneuver. | Other | Routine Care Group |
Primary outcome
Incidence of Perineal Trauma
Time frame: Immediately after birth
The occurrence of any perineal trauma following vaginal birth, including spontaneous perineal lacerations and episiotomy-related perineal injury.
1 secondary outcome
Postpartum Pain Score
Time frame: Within 2 hours 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 20 Jul 2026.
- Background: PubMed 28382061Ahmadi Z, Torkzahrani S, Roosta F, Shakeri N, Mhmoodi Z. Effect of Breathing Technique of Blowing on the Extent of Damage to the Perineum at the Moment of Delivery: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2017 Jan-Feb;22(1):62-66. doi: 10.4103/1735-9066.202071.
- Background: PubMed 16154062Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens Health. 2005 Sep-Oct;50(5):365-72. doi: 10.1016/j.jmwh.2005.05.012.
- Individual participant dataSharing planned: No
Related trials for Perineal Trauma
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Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
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THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
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.
Gozde Kugcumen study director
Medipol 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 Ritgen maneuver and Routine Care Group in people with Perineal Trauma and Ritgen Maneuver, run by Medipol 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 8 inclusion and 10 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 20 Jul 2026. 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?
Incidence of Perineal Trauma (time frame: Immediately after birth). 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 NCT07713173, which also lists 2 linked publications.
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 20 Jul 2026.