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Not Yet Recruiting NCT07925931

Simulation of Labor (SOL Study)

Conditions: Pregnancy, Labor and Childbirth, Fear of Birth

Sex: Female
Ages: 20 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: University of Padova

Summary

Fear of childbirth and low childbirth self-efficacy are recognized factors associated with negative birth experiences, increased anxiety, reduced maternal satisfaction, and a greater likelihood of obstetric interventions. Although antenatal education programs are widely used to prepare expectant parents for childbirth, considerable variability exists in their content and delivery, and many programs provide limited preparation for the emotional, relational, and organizational challenges encountered during labor and birth. This randomized controlled trial aims to evaluate the effectiveness of the Simulation of Labor (SOL) intervention, a personalized and experiential childbirth preparation program designed for primiparous women involving their birth partners. In addition to standard antenatal education, participants allocated to the intervention group will attend a structured labor simulation that reproduces labor and birth scenarios, hospital care processes, communication with healthcare professionals, non-pharmacological pain management strategies, and potential unexpected obstetric events. The simulation is tailored to participants' individual needs, concerns, and expectations identified before the intervention. Participants in the control group will receive standard antenatal education alone. The primary objective is to determine whether the SOL intervention reduces fear of childbirth before birth compared with standard antenatal education. Secondary objectives include evaluating childbirth self-efficacy, childbirth attitudes, birth experience, maternal participation in decision-making, obstetric interventions, mode of birth, and selected maternal and neonatal outcomes. The study will assess whether a personalized labor simulation can improve childbirth preparedness, strengthen parental competence and confidence, and promote a more positive and empowering birth experience.

Eligibility Criteria

Inclusion Criteria: * Pregnant women with singleton gestation * Gestational age ≥ 37 weeks (term pregnancy) * Cephalic fetal presentation * Absence of contraindications to vaginal birth * Primigravid women aged ≥ 20 years * Direct admission to the labor ward or stay in the antenatal ward \< 3 hours * Stable and long-term couple relationship * Italian-speaking couple * Attendance of a childbirth preparation course offered by a public and/or private service (online or in person) * Intention to give birth at the University Hospital of Padua Exclusion Criteria: * Pregnancies complicated by conditions that contraindicate vaginal birth * Breech presentation * Twin pregnancy * Preterm labor (\< 37 weeks) * Fetal malformations or fetal distress * Maternal conditions contraindicating vaginal birth * Multiparous women or women aged \< 20 years * Prolonged stay in the antenatal ward (\> 3 hours) * Unstable or short-term couple relationship * Significant psychiatric history or severe mental illness * Substance use or dependence * Refusal to provide informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07925931). StuddyBuddy aggregates publicly available trial information.