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NCT Number: NCT07492940

Hands-on vs Hands-off Techniques in 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears

    Time frame: Within two hours post-delivery

  2. Neonatal outcomes: umbilical cord pH

    Time frame: within 5 minutes of delivery

  3. Neonatal outcomes: Apgar score

    Time frame: within 5 minutes of birth

    Apgar score ≥ 7 at 5 minutes.

Secondary outcomes

  1. Parity

    Time frame: Baseline

  2. Ethnicity

    Time frame: Baseline

  3. Fetal malpositions during labor

    Time frame: Throughout the entire course of labor

  4. Maternal positions assumed during the expulsive phase

    Time frame: During the full duration of the second stage of labor

  5. Duration of the second stage of labor

    Time frame: During the full duration of the second stage of labor

  6. Birth with occiput in sacral rotation

    Time frame: periprocedural

  7. Presence of limb association

    Time frame: periprocedural

  8. Time from head to shoulders delivery

    Time frame: From the delivery of the fetal head until the completion of birth

  9. 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.

  10. Type of assistance provided (Hands-on / Hands-off)

    Time frame: Periprocedural

  11. Use of a birthing pool during the expulsive phase or water birth

    Time frame: During active labor and the second stage

  12. Use of lubricants during delivery

    Time frame: During the full duration of the second stage of labor

  13. Application of warm perineal compresses during the expulsive phase

    Time frame: During the full duration of the second stage of labor

  14. Maternal pushing technique and type of assistance provided by the operator

    Time frame: During the full duration of the second stage of labor

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Greco, dottoressa

CONTACT

[email protected]

00390444752628

Laura Tregnago, dottoressa

CONTACT

[email protected]

00390444752628

Sponsors and collaborators

Lead sponsor

Azienda ULSS 8 Berica

Other

Registry information

Official study title

The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.

Acronym: MPP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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