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Interdisciplinary Practice Bundle for Second-Stage of Labor and Clinical Outcomes

Effects of an Interdisciplinary Practice Bundle for Second-Stage of Labor on Clinical Outcomes

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07055490
Enrollment
200
Registered
2025-07-09
Start date
2025-07-15
Completion date
2025-11-15
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Outcomes

Keywords

Bundle, Clinical outcomes, Second satge

Brief summary

This study aims to assess the effect of implementing an interdisciplinary practice bundle during second-stage of labor on clinical outcomes.

Interventions

PROCEDUREInterdisciplinary Practice Bundle

interdisciplinary practices were combined in a bundle framework called (5-Ps) to maintain normal process during labor and prevent unnecessary routine interventions, which are (patience, positioning, physiological resuscitation, progress, and preventing urinary harm). These practices implemented from the beginning of the second stage of labor which is started from onset of complete cervical dilatation (10 cm) until delivery with a duration of 2 hours period.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
Yes

Inclusion criteria

* Primiparous women aged greater than 18 years, with normal pregnancy. * ≥ 38 weeks of gestation. * Eligible for normal vaginal delivery

Exclusion criteria

* women with high risk pregnancy. * Women with medical or psychological disorders. * Women suspected to cesarean birth.

Design outcomes

Primary

MeasureTime frameDescription
1- Fatigue Visual Analogue Scale (VAS-F),Study recruitment will take 6 months (from the beggining of July to the end of October, 2025) , all women who admitted to the labor and delivery unit at Mansoura University Hospitals, Egypt, were subjected to eligibility screening.Measurements I. Fatigue Visual Analogue Scale (VAS-F): a five point likert scale to assess fatigue post delivery.It is a self-reported scale consisted of 18 items relating to the subjective experience of fatigue with two subscales, fatigue (items 1-5 and 11-18) and energy (items 6-10). responces from not at all tired to extremely tired. The total score calculated from sum of all items and categorized mild fatigue ranging from 0-3, moderate fatigue ranging from 4-6, and severe fatigue ranging from 7-10.
2- Childbirth Experience Questionnaire (CEQ)Study recruitment will take 6 months (from the beggining of July to the end of October, 2025) , all women who admitted to the labor and delivery unit at Mansoura University Hospitals, Egypt, were subjected to eligibility screening.II. Childbirth Experience Questionnaire (CEQ). It is 22 items questionnaire yielded four domains (own capacity, perceived safety, professional support and participation. Scoring: Responses to 19 items were scored using a 4-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).

Contacts

Primary ContactEman A Fadel
e_a@mans.edu.eg+2 01002934749

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026