Perineal TraumaMPPNCT07492940
Hands-on vs Hands-off Techniques in Perineal Protection
An observational study of Perineal Trauma and Hands-on Technique, run by Azienda ULSS 8 Berica at 1 site in Italy.
Trial summary
Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Trauma, Hands-on Technique, Hands-of Technique
- How many people
- 737 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Full-term women with spontaneous vaginal birth (SVB)
Criteri di inclusione:
- Donne incinte nullipare o multipare
- Gravidanza a termine
- Feto nella presentazione cefalica
- Consegna eutocic (spontanea)
- Uso di ossitocina
- Uso di analgesici
Criteri di esclusione:
- Parto prematuro: prematuro tardivo -Disagio fetale acuto durante la fase di espulsione-
- Consegna della gretta
- Distocia della spalla
- Parto chirurgico (uso del vuoto ostetrico, manovra di Kristeller, taglio cesareo) --Episiotomia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Bortolo
Vicenza, Vicenza, 36100
Francesca Carolo, dottoressa, 0039444757088, francesca.carolo@aulss8.veneto.it
Francesca Rigo, dottoressa, 0039444753053, francesca.rigo@aulss8.veneto.it
About this study
Official title: The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
Perineal tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.
Read the detailed description
Perineal trauma remains a frequent occurrence during vaginal childbirth, leading clinicians to adopt various protective strategies. The two primary approaches are the hands-on technique, characterized by active manual support of the perineum and fetal head, and the hands-off (or expectant) technique, which prioritizes spontaneous delivery without manual intervention.
The objective of this study is to compare these two methods by evaluating their impact on both maternal and neonatal health.
Study Endpoints
The research focuses on primary outcomes related to perineal integrity-ranging from an intact perineum to varying degrees of lacerations (1st through 4th degree)-and neonatal well-being, specifically monitoring umbilical cord pH and Apgar scores (≥ 7 at 5 minutes).
To ensure a comprehensive analysis, the study also accounts for several secondary variables that may influence these outcomes:
Maternal \& Clinical Factors: Parity, ethnicity, and the duration of the second stage of labor.
Delivery Dynamics: Fetal malpositions, presentation at birth (including occiput posterior/sacral rotation), limb associations, and the transition time from head to shoulder delivery.
Procedural Interventions: The specific pushing technique used, maternal positions during the expulsive phase, and the use of water (birthing pool or water birth).
Supportive Measures: The application of warm compresses, the use of lubricants, and the specific assistance provided by the healthcare operator during the final contraction.
- Keywords
- Perineal trauma, Perineal injury, Perineal lacerations, Perineal tears, Obstetric anal sphincter injuries, OASIS, Genital tract trauma, Labial lacerations, Labial tears, Vaginal tears, Pelvic floor muscle injury, Levator ani muscle avulsion, First-degree perineal tear, Second-degree perineal tear, Third-degree perineal tear, Fourth-degree perineal tear, hands on, hands off, hands-on technique, hands-off technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hands-off group | Women receiving hands-off perineal support | |
| Hands-on group | Women receiving hands-on perineal support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears
Measured: Within two hours post-delivery
Neonatal outcomes: umbilical cord pH
Measured: within 5 minutes of delivery
Neonatal outcomes: Apgar score
Apgar score ≥ 7 at 5 minutes.
Measured: within 5 minutes of birth
Secondary outcomes (14)
Parity
Measured: Baseline
Ethnicity
Measured: Baseline
Fetal malpositions during labor
Measured: Throughout the entire course of labor
Maternal positions assumed during the expulsive phase
Measured: During the full duration of the second stage of labor
Duration of the second stage of labor
Measured: During the full duration of the second stage of labor
Birth with occiput in sacral rotation
Measured: periprocedural
Presence of limb association
Measured: periprocedural
Time from head to shoulders delivery
Measured: From the delivery of the fetal head until the completion of birth
Birth occurring with the same contraction as the head (single contraction)
Measured: From the delivery of the fetal head until the completion of birth.
Type of assistance provided (Hands-on / Hands-off)
Measured: Periprocedural
Use of a birthing pool during the expulsive phase or water birth
Measured: During active labor and the second stage
Use of lubricants during delivery
Measured: During the full duration of the second stage of labor
Application of warm perineal compresses during the expulsive phase
Measured: During the full duration of the second stage of labor
Maternal pushing technique and type of assistance provided by the operator
Measured: During the full duration of the second stage of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal TraumaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 737 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda ULSS 8 Berica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Greco, dottoressa, Study director, Aulss8 BericaLaura Tregnago, dottoressa, Principal investigator, Aulss8 Berica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492940
- Sponsor's protocol ID
- MF 11
- Other IDs
- Prot. n. 9674
- Acronym
- MPP
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
- ClinicalTrials.gov ID
- NCT07492940
- Acronym / sponsor ID
- MPP / MF 11
- Keywords
- Perineal trauma, Perineal injury, Perineal lacerations, Perineal tears, Obstetric anal sphincter injuries, OASIS, Genital tract trauma, Labial lacerations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 737 participants (estimated)
- Lead sponsor
- Azienda ULSS 8 BericaUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Mar 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 tears are frequent during vaginal delivery. This study evaluates the impact of hands-on versus hands-off techniques on perineal and neonatal outcomes to determine the most effective protective strategy.
Detailed description
Perineal trauma remains a frequent occurrence during vaginal childbirth, leading clinicians to adopt various protective strategies. The two primary approaches are the hands-on technique, characterized by active manual support of the perineum and fetal head, and the hands-off (or expectant) technique, which prioritizes spontaneous delivery without manual intervention.
The objective of this study is to compare these two methods by evaluating their impact on both maternal and neonatal health.
Study Endpoints
The research focuses on primary outcomes related to perineal integrity-ranging from an intact perineum to varying degrees of lacerations (1st through 4th degree)-and neonatal well-being, specifically monitoring umbilical cord pH and Apgar scores (≥ 7 at 5 minutes).
To ensure a comprehensive analysis, the study also accounts for several secondary variables that may influence these outcomes:
Maternal \& Clinical Factors: Parity, ethnicity, and the duration of the second stage of labor.
Delivery Dynamics: Fetal malpositions, presentation at birth (including occiput posterior/sacral rotation), limb associations, and the transition time from head to shoulder delivery.
Procedural Interventions: The specific pushing technique used, maternal positions during the expulsive phase, and the use of water (birthing pool or water birth).
Supportive Measures: The application of warm compresses, the use of lubricants, and the specific assistance provided by the healthcare operator during the final contraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands-off group | – | –Women receiving hands-off perineal support |
| Hands-on group | – | –Women receiving hands-on perineal support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Full-term women with spontaneous vaginal birth (SVB)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears
Time frame: Within two hours post-delivery
Neonatal outcomes: umbilical cord pH
Time frame: within 5 minutes of delivery
Neonatal outcomes: Apgar score
Time frame: within 5 minutes of birth
Apgar score ≥ 7 at 5 minutes.
14 secondary outcomes
Parity
Time frame: Baseline
Ethnicity
Time frame: Baseline
Fetal malpositions during labor
Time frame: Throughout the entire course of labor
Maternal positions assumed during the expulsive phase
Time frame: During the full duration of the second stage of labor
Duration of the second stage of labor
Time frame: During the full duration of the second stage of labor
Birth with occiput in sacral rotation
Time frame: periprocedural
Presence of limb association
Time frame: periprocedural
Time from head to shoulders delivery
Time frame: From the delivery of the fetal head until the completion of birth
Birth occurring with the same contraction as the head (single contraction)
Time frame: From the delivery of the fetal head until the completion of birth.
Type of assistance provided (Hands-on / Hands-off)
Time frame: Periprocedural
Use of a birthing pool during the expulsive phase or water birth
Time frame: During active labor and the second stage
Use of lubricants during delivery
Time frame: During the full duration of the second stage of labor
Application of warm perineal compresses during the expulsive phase
Time frame: During the full duration of the second stage of labor
Maternal pushing technique and type of assistance provided by the operator
Time frame: During the full duration of the second stage of labor
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
Jessica Greco, dottoressa study director
Aulss8 Berica
Laura Tregnago, dottoressa principal investigator
Aulss8 Berica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perineal Trauma and Hands-on Technique, run by Azienda ULSS 8 Berica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 25 Mar 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Greco, dottoressa (00390444752628, jessica.greco@aulss8.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears (time frame: Within two hours post-delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.