Hands-on vs Hands-off Techniques in Perineal Protection (MPP)

Azienda ULSS 8 Berica

Status

Enrolling

Conditions

Perineal Trauma

Manual Perineal Protection

Hands-of Technique

Hands-on Technique

Study type

Observational

Funder types

Other

Identifiers

NCT07492940

Prot. n. 9674 (Other Identifier)

MF 11

Details and patient eligibility

About

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.

Full 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.

Enrollment

737 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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