Delivery OutcomesNCT07055490
Interdisciplinary Practice Bundle for Second-Stage of Labor and Clinical Outcomes
A study testing Interdisciplinary Practice Bundle in people with Delivery Outcomes, run by Mansoura University.
Trial summary
This study aims to assess the effect of implementing an interdisciplinary practice bundle during second-stage of labor on clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery Outcomes
- What is being tested?
- Interdisciplinary Practice Bundle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women aged greater than 18 years, with normal pregnancy.
- ≥ 38 weeks of gestation.
- Eligible for normal vaginal delivery
Who cannot join
- women with high risk pregnancy.
- Women with medical or psychological disorders.
- Women suspected to cesarean birth.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of an Interdisciplinary Practice Bundle for Second-Stage of Labor on Clinical Outcomes
This study aims to assess the effect of implementing an interdisciplinary practice bundle during second-stage of labor on clinical outcomes.
- Conditions
- Delivery Outcomes
- Being tested
- Interdisciplinary Practice Bundle
- Keywords
- Bundle, Clinical outcomes, Second satge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary Practice BundleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Apply interdisciplinary practice bundle during second-stage of labor | Experimental | 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. Receives: Procedure: Interdisciplinary Practice Bundle |
| control group | No intervention | receive the routine hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Fatigue Visual Analogue Scale (VAS-F),
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.
Measured: 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.
2- Childbirth Experience Questionnaire (CEQ)
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery OutcomesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Fadel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055490
- Sponsor's protocol ID
- IRB. 0591
- Status last verified
- May 2025
- First submitted
- 17 Mar 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Interdisciplinary Practice Bundle for Second-Stage of Labor on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07055490
- Acronym / sponsor ID
- IRB. 0591
- Conditions
- Delivery Outcomes
- Keywords
- Bundle, Clinical outcomes, Second satge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of implementing an interdisciplinary practice bundle during second-stage of labor on clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apply interdisciplinary practice bundle during second-stage of labor | Experimental | Procedure: Interdisciplinary Practice Bundleinterdisciplinary 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 | No intervention | –receive the routine hospital care |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primiparous women aged greater than 18 years, with normal pregnancy.
- ≥ 38 weeks of gestation.
- Eligible for normal vaginal delivery
Key exclusion criteria (3 listed)
- women with high risk pregnancy.
- Women with medical or psychological disorders.
- Women suspected to cesarean birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary Practice Bundleinterdisciplinary 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. | Procedure or surgery | Apply interdisciplinary practice bundle during second-stage of labor |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary Practice Bundle in people with Delivery Outcomes, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman A Fadel (+2 01002934749, e_a@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.