Simulation of Labor (SOL Study)
NCT07925931, Not applicable, Not yet recruiting, University of Padova
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Simulation of Labor (SOL Study) | ClinicalTrials.gov |
| NCT number | NCT07925931 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 72 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Padova | ClinicalTrials.gov |
| Conditions | Pregnancy, Labor and Childbirth, Fear of Birth | ClinicalTrials.gov |
| Interventions | Simulation of Labor, No intervention | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Between-group difference in change in childbirth fear score | Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week | Between-group difference in change in childbirth fear score, measured using the Wijma Delivery Expectancy/Experience Questionnaire A, from: Pre-intervention/baseline: assessment performed before the simulation for the intervention group and before completion of the standard childbirth preparation course for the control group. Post-intervention, before birth: assessment performed after the intervention (simulation) for the intervention group and after completion of the standard childbirth preparation course for the control group. Responses will be collected within 1 week after the intervention/course completion. | ClinicalTrials.gov |
| Secondary | Between-group difference in perceived childbirth self-efficacy before birth. | Within one week after the simulation or the completion of standard antenatal education | Between-group difference in perceived childbirth self-efficacy before birth, assessed using the Childbirth Self-Efficacy Inventory. | ClinicalTrials.gov |
| Secondary | Between-group difference in childbirth attitude (preference) | Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week | Between-group difference in childbirth attitude (preference) before birth, assessed through preferred mode of delivery (vaginal delivery or cesarean section). | ClinicalTrials.gov |
| Secondary | Between-group difference in change in childbirth fear score, measured using the Childbirth Attitude Questionnaire | Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week | Between-group difference in change in childbirth fear score, measured using the Childbirth Attitude Questionnaire pre-intervention and post intervention (before birth) | ClinicalTrials.gov |
| Secondary | Between-group difference in childbirth fear after delivery, measured using the Wijma Delivery Expectancy/Experience Questionnaire B | Within one week after delivery | Between-group difference in childbirth fear after delivery, measured using the Wijma Delivery Expectancy/Experience Questionnaire B at postpartum assessment. | ClinicalTrials.gov |
| Secondary | Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Wijma Delivery Expectancy/Experience Questionnaire A | Between enrolment (before simulation) and simulation within one week after the completion | Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Wijma Delivery Expectancy/Experience Questionnaire A, assessed before simulation or standard antenatal educatione and after simulation or standard antenatal education | ClinicalTrials.gov |
| Secondary | Difference in the duration of labor stages between groups | Within one week after delivery | Difference in the duration of labor stages between groups (in minutes) extracted from clinical records. | ClinicalTrials.gov |
| Secondary | Between-group difference in the use of medical procedures to accelerate labor | Within one week after delivery | Between-group difference in the use of medical procedures to accelerate labor, such as amniotomy or oxytocin administration (from clinical records). | ClinicalTrials.gov |
| Secondary | Difference in mode of delivery between groups | Within one week after delivery | Difference in mode of delivery between groups (vaginal birth vs cesarean or operative delivery) assessed using clinical records | ClinicalTrials.gov |
| Secondary | Difference in neonatal Apgar scores between groups. | Within one week after delivery | Difference in neonatal Apgar scores (at fist minute expressed from 1 to 10/10) between groups assessed using clinical records. | ClinicalTrials.gov |
| Secondary | Difference in active participation and negotiation ability of the woman/couple (subjective outcome) | Within one week after delivery | Difference in active participation and negotiation ability of the woman/couple, assessed through postpartum narrative interviews (birth narratives), in particular regarding the autonomous use of non-pharmacological pain-management strategies during labor (vocalizations, visualizations, warm water, emotional anchoring, acupressure, movement and position changes, music, dim lighting, and behaviors promoting hormonal regulation), negotiation and clarification regarding invasive procedures, and overall perception of a positive and satisfying birth experience. | ClinicalTrials.gov |
| Secondary | Perceived effectiveness of simulation versus traditional childbirth class | Within one week after delivery | Perceived effectiveness of simulation versus traditional childbirth class (10-point Likert scale), assessed through a postpartum questionnaire in both groups, including: reduction of disorientation during labor, increased partner activation and involvement, clearer understanding of professional care and obstetric procedures, reduced perception of partner uselessness during labor, and increased maternal sense of empowerment in managing childbirth. | ClinicalTrials.gov |
| Secondary | Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Childbirth Attitude Questionnaire | Between enrolment (before simulation) and simulation within one week after the completion | Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Childbirth Attitude Questionnaire, assessed before simulation and after simulation | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 33663905 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)