Hands-of Technique, Hands-on Technique, Manual Perineal Protection, Perineal Trauma
Conditions
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
Brief 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.
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.
Interventions
None listed
Sponsors
Azienda ULSS 8 Berica
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal outcomes: intact perineum; first-, second-, third-, and fourth-degree perineal tears | Within two hours post-delivery | — |
| Neonatal outcomes: umbilical cord pH | within 5 minutes of delivery | — |
| Neonatal outcomes: Apgar score | within 5 minutes of birth | Apgar score ≥ 7 at 5 minutes. |
Secondary
| Measure | Time frame |
|---|---|
| Parity | Baseline |
| Ethnicity | Baseline |
| Fetal malpositions during labor | Throughout the entire course of labor |
| Maternal positions assumed during the expulsive phase | During the full duration of the second stage of labor |
| Duration of the second stage of labor | During the full duration of the second stage of labor |
| Birth with occiput in sacral rotation | periprocedural |
| Presence of limb association | periprocedural |
| Time from head to shoulders delivery | From the delivery of the fetal head until the completion of birth |
| Birth occurring with the same contraction as the head (single contraction) | From the delivery of the fetal head until the completion of birth. |
| Type of assistance provided (Hands-on / Hands-off) | Periprocedural |
| Use of a birthing pool during the expulsive phase or water birth | During active labor and the second stage |
| Use of lubricants during delivery | During the full duration of the second stage of labor |
| Application of warm perineal compresses during the expulsive phase | During the full duration of the second stage of labor |
| Maternal pushing technique and type of assistance provided by the operator | During the full duration of the second stage of labor |
Countries
Italy
Contacts
CONTACTJessica Greco, dottoressa
CONTACTLaura Tregnago, dottoressa
STUDY_DIRECTORJessica Greco, dottoressa
Aulss8 Berica
PRINCIPAL_INVESTIGATORLaura Tregnago, dottoressa
Aulss8 Berica
Outcome results
None listed