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NCT Number: NCT07055490

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

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

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Key information

Conditions

Delivery Outcomes

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interdisciplinary Practice Bundle

Procedure

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.

Primary outcomes

1- Fatigue Visual Analogue Scale (VAS-F),

Time frame: 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)

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eman A Fadel

CONTACT

[email protected]

+2 01002934749

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 9, 2025
Registry last updated: Jul 9, 2025

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.