- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392660
Upright Position During First Stage of Labour
May 23, 2022 updated by: Rabab sabry hassen mohamed, Cairo University
Effect of Upright Position During First Stage of Labour On Labour Outcome: An Evidence Based Approach
There are several physiological advantages for being upright during labour.
These include the effect of gravity on the fetus within the uterus; reduced risk of aorto-caval compression this maximizes uterine blood flow to the placenta and fetus during labour and more efficient contractions which lead to shorter first and second stage of labor.
In addition, being upright during labour provide better alignment of the fetus; and increased pelvic outlet when the woman is in squatting and kneeling positions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
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 Locations
-
-
-
Cairo, Egypt, 11553
- Faculty of Nursing Cairo University
-
-
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
16 years to 31 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Primipara parturient women who admitted to delivery unit;
- in early active phase of 1st stage of labor (not more than 4cm),
- age between 20-35 years,
- had a single, viable, and full term (≥ 37 weeks),
- with normal fetal heart rate pattern (120-160 b/min),
- fetus in occipto anterior position
- free from medical or obstetrical disorders that may interrupt labor progress
Exclusion Criteria:
- Any women out of inclusion criteria
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study arm
assumed upright position during first stage of labor
|
The study group assumed one of upright positions during first stage of labor, defined as walking , sitting, standing, kneeling & squatting positions )
|
|
No Intervention: control arm
hospital routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity of labor pain assessed by Visual analogue pain intensity scale
Time Frame: during the procedure
|
Assessment of labor pain assessed by VAS (Visual analogue pain intensity scale ).It is a self-reported 10 cm horizontal line which represented the subjective estimation of pain intensity.
It comprised 0-10-point numerical scale, No pain (0), Mild pain (< 4), Moderate pain (4-6), Sever pain (7-10).
|
during the procedure
|
|
duration of first stage of labor
Time Frame: during the procedure
|
upright position may decrease the duration of first stage of labor
|
during the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
duration of second stage of labor
Time Frame: immediately after intervention
|
upright position may decrease the duration of second stage of labor
|
immediately after intervention
|
|
fetal outcome
Time Frame: during the procedure
|
fetal well being through fetal heart rate assessment assessed by CTG (cardio toco graph ) machine
|
during the procedure
|
|
Neonatal outcome
Time Frame: immediately after intervention
|
neonatal condition after delivery assessed by a standardized APGAR score tool by allocating scores to five simple criteria Activity (Muscle tone), Pulse (Heart rate), Grimace (reflex irritability) Appearance (Skin color) & Respiratory effort (breathing).
A total score (0-3) revealed sever neonatal distress, (4-7) indicated moderate distress & (8-10) indicated absence of difficulty in adjusting to extra uterine live.
|
immediately after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 2, 2019
Primary Completion (Actual)
March 27, 2020
Study Completion (Actual)
March 27, 2020
Study Registration Dates
First Submitted
May 19, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2014
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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