- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04641572
Different Positions During Childbirth
November 17, 2020 updated by: Howieda Fouly, Woman's Health University Hospital, Egypt
Application the Recommended Positions of the World Health Organization During Normal Childbirth and Its Effect on Maternal and Labor Outcomes
To encourage the application the recommended positions of the World Health Organization during normal childbirth and its effect on maternal and labor outcomes
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To assess the effects of adopting upright positions (walking, sitting, standing) during first stage of labor.
To measure the effect of different individual positions on maternal-fetal outcomes.
To determine which position was more comfortable for women.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Howieda Fouly, PhD
- Phone Number: 0538472739
- Email: hoida_elfouly@yahoo.com
Study Contact Backup
- Name: Safaa Helmi, PhD
- Phone Number: 00201033892209
- Email: safaa_helmi@yahoo.com
Study Locations
-
-
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Asyut, Egypt, 71111
- Recruiting
- Woman Health Hospital
-
Contact:
- Howieda Ahmed A Fouly, PhD
- Phone Number: 01011993216
- Email: hoida.elfouly@aun.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- aged > 18 years old with normal pregnancy, primiparas and multi-paras labor cases.
Exclusion Criteria:
- All high-risk associated factors (Hypertension- DM, Heart disease- renal disease) will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Supine position
group A ( control ) will follow the hospital routine positions either supine or lateral during labor
|
|
Experimental: Upright position
Group B (intervention) will follow the Standing or walking, Squatting, Sitting, Hands /knees, and Kneeling, positions.
Then the researcher will register the time ( minutes/hours) that will be taken and which will be more preferable by the participant.
|
Standing or walking, Squatting, Sitting, Hands /knees, and Kneeling, positions will be taken by the participant during labor.Then the researcher will register the time ( minutes/hours) will be taken and which that will be more preferable by the participant
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The maternal outcome.
Time Frame: Within labor process
|
measure labor pain score in each position on pain scale
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Within labor process
|
Newborn outcome
Time Frame: At 1 minute and 5 minutes after delivery.
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Measure the APGAR score of the newborn related to each position
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At 1 minute and 5 minutes after delivery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
-Increase self-direction of participants through choosing the preferable position
Time Frame: Within labor process
|
Register the most preferable positions during childbirth process
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Within labor process
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Improve women's satisfaction of childbirth experience
Time Frame: After childbirth process.
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measure woman's satisfaction after application of the upright position
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After childbirth process.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Howieda Fouly, PhD, Woman's Health Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
July 5, 2020
First Submitted That Met QC Criteria
November 17, 2020
First Posted (Actual)
November 24, 2020
Study Record Updates
Last Update Posted (Actual)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 17, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Woman's health Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data only will be available for the study co-investigators.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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