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Not Yet Recruiting NCT05612321

Vacuum Delivery in All-fours Position vs Traditional Position

Conditions: Prolonged Second Stage of Labor, Prolonged Second Stage of Labor Due to Poor Maternal Effort

Sex: Female
Ages: 18 Years – 45 Years
Phase: NA
Enrollment: 250
Sponsor: Ospedale degli Infermi di Biella

Summary

The aim of the study is to investigate the safety, clinical efficacy and the maternal/neonatal outcomes of vacuum application in all-fours position compared with supine traditional position, in women undergoing vacuum-assisted delivery during the second stage of labor.The main question it aims to answer are:Does the rate of failure of vacuum delivery, measured as number of cup detachments and the need of emergency caesarean section is lower if vacuum delivery is performed on a woman in all-fours position?Do maternal and fetal outcomes are better in case vacuum delivery in all-fours position?Participants will be randomly enrolled at the admission in two different groups, Control and Experimental Group, and in case of need for vacuum-assisted vaginal delivery; women belonging to Control Group will undergo vacuum-assisted delivery in traditional supine position, while women in Experimental Group will experience vacuum application in all-fours position.Researchers will compare the Group A, composed by women who undergo vacuum-delivery in traditional supine position, with Group B, in which women are in "all-fours" position, to see if hands-and-knees position provides better outcomes.

Eligibility Criteria

Inclusion Criteria:womensingletoncephalic presentationterm pregnancysecond stage of laborfailure to progressmaternal wearinessneed for operative vaginal delivery by vacuum extractionExclusion Criteria:enrollment refusalabsence of consentcontraindication to operative vaginal delivery

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05612321). StuddyBuddy aggregates publicly available trial information.