Perineal Tear4PNCT04616170
The Patient Positioning for Perineal Protection Study
A study testing Hip extension in people with Perineal Tear and Delivery; Trauma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this forced stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Tear, Delivery; Trauma, Perineal Laceration
- What is being tested?
- Hip extension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 11 Jul 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women
- Non-anomalous fetuses
- Term gestation
- Vertex presentation
- Eligible for trial of labor
Who cannot join
- Multiparous women
- Prior perineal malformations
- History female genital mutilation
- Prior perineal surgery
- Anomalous fetuses
- Multiple gestations
- Fetal status incompatible with labor
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this forced stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. This study will examine whether extending the hips, as compared to usual care, at the time of crowning of the fetal vertex during vaginal delivery decreases maternal perineal trauma among nulliparous women.
Read the detailed description
Perineal trauma at the time of vaginal delivery is a significant cause of maternal morbidity including vaginal pain, dyspareunia, urinary incontinence, infection, and social isolation in severe cases. There are well known risk factors in the literature for OASIS (obstetric anal sphincter injuries), however, this literature is by no means comprehensive. A prior RCT in 2012 looked at the role of patient positioning at the time of pushing and delivery to determine whether stirrup positioning and forced hip flexion leads to higher rates of any perineal tears. The study concluded that stirrup positioning did not lead to higher rates of perineal tearing but was not powered to evaluate the role of positioning on OASIS tears or on postpartum perineal morbidity.
In addition to lacking data with respect to patient positioning, data is limited regarding perineal morbidity beyond the traditional grading system of 1st, 2nd, 3rd, and 4th degree tears. 3rd and 4th degree lacerations are labeled as OASIS, however, perineal morbidity can result from "lower" orders of perineal tearing at the time of delivery. Prior studies have tried to illustrate various subsets of second degree lacerations in an attempt to subdivide 2nd degree lacerations into categories of severity, however, little has been done in practice with this form of division and little is written on the topic of perineal morbidity beyond OASIS tears.
It is common practice for practitioners to instruct patients to flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. The closest studies to examine this have been in comparing women who deliver in the squatting position compared to in lithotomy. Those who deliver in squatting positions have been found to have deeper perineal lacerations, which demonstrate the possibility that forced flexion at the hips could lead to the same outcome in the lithotomy position. Should research show an increased risk of morbidity with this near universal positioning practice as compared to hip extension, this study could change practice patterns for the betterment of patients worldwide.
- Conditions
- Perineal Tear, Delivery; Trauma, Perineal Laceration
- Being tested
- Hip extension, Usual Care
- Keywords
- perineal tear, perineal laceration, vaginal delivery, delivery position
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip extensionOther
Hips extended at the time of vaginal delivery
Usual CareOther
Hips positioned in the "usual care" position per provider preference at the time of vaginal delivery
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Patients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery. Receives: Other: Usual Care |
| Hip extension | Experimental | Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery. Receives: Other: Hip extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of perineal laceration
The degree of perineal laceration as classified by the American College of Obstetricians and Gynecologists (ACOG) classification system
Measured: At the time of vaginal delivery
Secondary outcomes (1)
Rate of OASIS laceration
Number of obstetric anal sphincter injury lacerations compared to all deliveries
Measured: At the time of vaginal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start5 Apr 2021
- Primary completion11 Jul 2025
- Study completion11 Jul 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 Perineal TearStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Patients will be assigned to usual care or hip extension at the time of delivery of the fetal vertex
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William H. Barth, Jr., MD, Massachusetts General Hospital
- Investigators
- Marti D Soffer, MD MPH, Study director, Massachusetts General HospitalWilliam H Barth, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616170
- Sponsor's protocol ID
- 2020P003603
- Acronym
- 4P
- Status last verified
- Jul 2025
- First submitted
- 26 Oct 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soffer MD, James KE, Liang P, Delgado A, Mossayebi MH, Hamp M, Siegel MR, Clapp MA, Kaimal AJ, Barth WH Jr. Effect of Hip Extension Compared With Usual Positioning on Perineal Lacerations During First Vaginal Delivery: A Randomized Clinical Trial. Obstet Gynecol. 2026 Sep 22. doi: 10.1097/AOG.0000000000006438. Online ahead of print.
PubMed 42771819
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient Positioning for Perineal Protection Study
- ClinicalTrials.gov ID
- NCT04616170
- Acronym / sponsor ID
- 4P / 2020P003603
- Conditions
- Perineal Tear, Delivery; Trauma, Perineal Laceration
- Keywords
- perineal tear, perineal laceration, vaginal delivery, delivery position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 4 Nov 2020 (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.
It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this forced stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. This study will examine whether extending the hips, as compared to usual care, at the time of crowning of the fetal vertex during vaginal delivery decreases maternal perineal trauma among nulliparous women.
Detailed description
Perineal trauma at the time of vaginal delivery is a significant cause of maternal morbidity including vaginal pain, dyspareunia, urinary incontinence, infection, and social isolation in severe cases. There are well known risk factors in the literature for OASIS (obstetric anal sphincter injuries), however, this literature is by no means comprehensive. A prior RCT in 2012 looked at the role of patient positioning at the time of pushing and delivery to determine whether stirrup positioning and forced hip flexion leads to higher rates of any perineal tears. The study concluded that stirrup positioning did not lead to higher rates of perineal tearing but was not powered to evaluate the role of positioning on OASIS tears or on postpartum perineal morbidity.
In addition to lacking data with respect to patient positioning, data is limited regarding perineal morbidity beyond the traditional grading system of 1st, 2nd, 3rd, and 4th degree tears. 3rd and 4th degree lacerations are labeled as OASIS, however, perineal morbidity can result from "lower" orders of perineal tearing at the time of delivery. Prior studies have tried to illustrate various subsets of second degree lacerations in an attempt to subdivide 2nd degree lacerations into categories of severity, however, little has been done in practice with this form of division and little is written on the topic of perineal morbidity beyond OASIS tears.
It is common practice for practitioners to instruct patients to flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. The closest studies to examine this have been in comparing women who deliver in the squatting position compared to in lithotomy. Those who deliver in squatting positions have been found to have deeper perineal lacerations, which demonstrate the possibility that forced flexion at the hips could lead to the same outcome in the lithotomy position. Should research show an increased risk of morbidity with this near universal positioning practice as compared to hip extension, this study could change practice patterns for the betterment of patients worldwide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to usual care or hip extension at the time of delivery of the fetal vertex
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual CarePatients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery. |
| Hip extension | Experimental | Other: Hip extensionPatients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparous women
- Non-anomalous fetuses
- Term gestation
- Vertex presentation
- Eligible for trial of labor
Key exclusion criteria (7 listed)
- Multiparous women
- Prior perineal malformations
- History female genital mutilation
- Prior perineal surgery
- Anomalous fetuses
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 |
|---|---|---|
| Hip extensionHips extended at the time of vaginal delivery | Other | Hip extension |
| Usual CareHips positioned in the "usual care" position per provider preference at the time of vaginal delivery | Other | Usual care |
Primary outcome
Classification of perineal laceration
Time frame: At the time of vaginal delivery
The degree of perineal laceration as classified by the American College of Obstetricians and Gynecologists (ACOG) classification system
1 secondary outcome
Rate of OASIS laceration
Time frame: At the time of vaginal delivery
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 Jul 2025.
- Derived from this study: PubMed 42771819Soffer MD, James KE, Liang P, Delgado A, Mossayebi MH, Hamp M, Siegel MR, Clapp MA, Kaimal AJ, Barth WH Jr. Effect of Hip Extension Compared With Usual Positioning on Perineal Lacerations During First Vaginal Delivery: A Randomized Clinical Trial. Obstet Gynecol. 2026 Sep 22. doi: 10.1097/AOG.0000000000006438. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Perineal Tear
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Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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Pregnancy, Childbirth
RecruitingObservational study
Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.
Vaginal Laceration During Delivery
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.
Marti D Soffer, MD MPH study director
Massachusetts General Hospital
William H Barth, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip extension in people with Perineal Tear and Delivery; Trauma, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 7 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 Jul 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 United States. 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?
Classification of perineal laceration (time frame: At the time of vaginal delivery). 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 NCT04616170, 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 Jul 2025.