Ospedale San Bortolo
Vicenza, 36100, Italy
Location status: Recruiting
Location contact
Francesca Carolo, dottoressa
CONTACT
Francesca Rigo, dottoressa
CONTACT
NCT Number: NCT07492940
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Vicenza, 36100, Italy
Location status: Recruiting
Francesca Carolo, dottoressa
CONTACT
Francesca Rigo, dottoressa
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Criteri di inclusione:
Criteri di esclusione:
Time frame: Within two hours post-delivery
Time frame: within 5 minutes of delivery
Time frame: within 5 minutes of birth
Apgar score ≥ 7 at 5 minutes.
Time frame: Baseline
Time frame: Baseline
Time frame: Throughout the entire course of labor
Time frame: During the full duration of the second stage of labor
Time frame: During the full duration of the second stage of labor
Time frame: periprocedural
Time frame: periprocedural
Time frame: From the delivery of the fetal head until the completion of birth
Time frame: From the delivery of the fetal head until the completion of birth.
Time frame: Periprocedural
Time frame: During active labor and the second stage
Time frame: During the full duration of the second stage of labor
Time frame: During the full duration of the second stage of labor
Time frame: During the full duration of the second stage of labor
Contact information is provided by the study sponsor or research team.
Jessica Greco, dottoressa
CONTACT
Laura Tregnago, dottoressa
CONTACT
Azienda ULSS 8 Berica
Other
The Midwife's Hands Between Waiting and Support: Hands-off vs hands-on Techniques in Manual Perineal Protection.
Acronym: MPP
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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