Effects of MovementNCT05392660
Upright Position During First Stage of Labour
A study testing assumed upright position during first stage of labor in people with Effects of Movement, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Effects of Movement
- What is being tested?
- assumed upright position during first stage of labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2019to 27 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any women out of inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Effects of Movement
- Being tested
- assumed upright position during first stage of labor
- Keywords
- First stage of labor, Upright position, Labor outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assumed upright position during first stage of laborOther
The study group assumed one of upright positions during first stage of labor, defined as walking , sitting, standing, kneeling \& squatting positions )
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | assumed upright position during first stage of labor Receives: Other: assumed upright position during first stage of labor |
| control arm | No intervention | hospital routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of labor pain assessed by Visual analogue pain intensity scale
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).
Measured: during the procedure
duration of first stage of labor
upright position may decrease the duration of first stage of labor
Measured: during the procedure
Secondary outcomes (3)
duration of second stage of labor
upright position may decrease the duration of second stage of labor
Measured: immediately after intervention
fetal outcome
fetal well being through fetal heart rate assessment assessed by CTG (cardio toco graph ) machine
Measured: during the procedure
Neonatal outcome
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.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start2 Jan 2019
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of MovementStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab sabry hassen mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392660
- Sponsor's protocol ID
- 2014
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 26 May 2022
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Upright Position During First Stage of Labour On Labour Outcome: An Evidence Based Approach
- ClinicalTrials.gov ID
- NCT05392660
- Acronym / sponsor ID
- 2014
- Conditions
- Effects of Movement
- Keywords
- First stage of labor, Upright position, Labor outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 26 May 2022 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Other: assumed upright position during first stage of laborassumed upright position during first stage of labor |
| control arm | No intervention | –hospital routine care |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (1 listed)
- Any women out of inclusion criteria
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 |
|---|---|---|
| assumed upright position during first stage of laborThe study group assumed one of upright positions during first stage of labor, defined as walking , sitting, standing, kneeling \& squatting positions ) | Other | study arm |
Primary outcome
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).
duration of first stage of labor
Time frame: during the procedure
upright position may decrease the duration of first stage of labor
3 secondary outcomes
duration of second stage of labor
Time frame: immediately after intervention
fetal outcome
Time frame: during the procedure
Neonatal outcome
Time frame: immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assumed upright position during first stage of labor in people with Effects of Movement, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of labor pain assessed by Visual analogue pain intensity scale (time frame: during the procedure). 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 26 May 2022.