Hands-on vs Hands-off Techniques in Perineal Protection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Perineal Trauma, Hands-on Technique, Hands-of Technique, Manual Perineal Protection. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Ospedale San Bortolo — Vicenza
Identifiers
NCT: NCT07492940 · MF 11 · Prot. n. 9674