Childbirth ProcessNCT04641572
Different Positions During Childbirth
A study testing Choose comfortable position in people with Childbirth Process, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
To encourage the application the recommended positions of the World Health Organization during normal childbirth and its effect on maternal and labor outcomes Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Process
- What is being tested?
- Choose comfortable position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 30 Dec 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged > 18 years old with normal pregnancy, primiparas and multi-paras labor cases.
Who cannot join
- All high-risk associated factors (Hypertension- DM, Heart disease- renal disease) will be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Woman Health Hospital
Asyut, 71111
Howieda Ahmed A Fouly, PhD, 01011993216, hoida.elfouly@aun.edu.eg
Ahmed Abbas, MD, 00201003385183, bmr90@hotmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Childbirth Process
- Being tested
- Choose comfortable position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choose comfortable positionOther
Also called change position
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
| Study group | Role | What they receive |
|---|---|---|
| Supine position | No intervention | group A ( control ) will follow the hospital routine positions either supine or lateral during labor |
| Upright position | Experimental | 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. Receives: Other: Choose comfortable position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maternal outcome.
measure labor pain score in each position on pain scale
Measured: Within labor process
Newborn outcome
Measure the APGAR score of the newborn related to each position
Measured: At 1 minute and 5 minutes after delivery.
Secondary outcomes (2)
-Increase self-direction of participants through choosing the preferable position
Register the most preferable positions during childbirth process
Measured: Within labor process
Improve women's satisfaction of childbirth experience
measure woman's satisfaction after application of the upright position
Measured: After childbirth process.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Jun 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ProcessStudies of the same condition, open and under way.
- 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
- Model description
- Random selection based on the woman's preference for certain positions during her first stage of labor.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howieda Fouly, Woman's Health University Hospital, Egypt
- Investigators
- Howieda Fouly, PhD, Principal investigator, Woman's Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641572
- Sponsor's protocol ID
- Woman's health Hospital
- Status last verified
- Oct 2020
- First submitted
- 5 Jul 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data only will be available for the study co-investigators.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application the Recommended Positions of the World Health Organization During Normal Childbirth and Its Effect on Maternal and Labor Outcomes
- ClinicalTrials.gov ID
- NCT04641572
- Acronym / sponsor ID
- Woman's health Hospital
- Conditions
- Childbirth Process
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 24 Nov 2020 (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.
To encourage the application the recommended positions of the World Health Organization during normal childbirth and its effect on maternal and labor outcomes
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Random selection based on the woman's preference for certain positions during her first stage of labor.
| Arm | Type | Receives |
|---|---|---|
| Supine position | No intervention | –group A ( control ) will follow the hospital routine positions either supine or lateral during labor |
| Upright position | Experimental | Other: Choose comfortable positionGroup 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- aged > 18 years old with normal pregnancy, primiparas and multi-paras labor cases.
Key exclusion criteria (1 listed)
- All high-risk associated factors (Hypertension- DM, Heart disease- renal disease) will be excluded.
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 |
|---|---|---|
| Choose comfortable positionAlso: change positionStanding 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 | Upright position |
Primary outcome
The maternal outcome.
Time frame: Within labor process
measure labor pain score in each position on pain scale
Newborn outcome
Time frame: At 1 minute and 5 minutes after delivery.
Measure the APGAR score of the newborn related to each position
2 secondary outcomes
-Increase self-direction of participants through choosing the preferable position
Time frame: Within labor process
Improve women's satisfaction of childbirth experience
Time frame: After childbirth process.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No. The data only will be available for the study co-investigators.
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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.
Howieda Fouly, PhD principal investigator
Woman's Health Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choose comfortable position in people with Childbirth Process, run by Woman's Health University Hospital, Egypt 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 1 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Howieda Fouly, PhD (0538472739, hoida_elfouly@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maternal outcome. (time frame: Within labor process). 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 24 Nov 2020.