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

NCT ID: NCT07055490

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-11-15

Brief Summary

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

Detailed Description

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Conditions

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Delivery Outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Apply interdisciplinary practice bundle during second-stage of labor

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.

Group Type EXPERIMENTAL

Interdisciplinary Practice Bundle

Intervention Type 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.

control group

receive the routine hospital care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Interdisciplinary 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Eman Ahmed Fadel

Assis. professor of Woman's Health & Midwifery Nursing, Principal Investigator.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Eman A Fadel

Role: CONTACT

+2 01002934749

Other Identifiers

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IRB. 0591

Identifier Type: -

Identifier Source: org_study_id

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