Birth, FirstNCT04883541
Effects of Yoga and Meditation on The Birth Process
A study testing yoga and meditation and Birth preparation training in people with Birth, First and Labor Pain, run by Uskudar University.
Trial summary
Introduction: Today it is seen that women lose their birthing strength, give the control to healthcare personnel during labour and the rate of c-section or interventional labour is increasing. For this reason, the importance of yoga, meditation and breath awareness practices increases during pregnancy and birth. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First, Labor Pain, State Anxiety
- What is being tested?
- yoga and meditation and Birth preparation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women,
- Primiparous and between 20-36 gestational weeks,
- Single fetuses, expected to give birth normally and spontaneously,
- No pregnancy complications and systemic disease,
- Speak Turkish
Who cannot join
- Being unable to speak Turkish
- Having a history of serious illness that threatens life or because of these reasons.
- Currently or previously due to a serious mental weakness or illness
- Being diagnosed with a psychiatric diagnosis and being treated for this reason,
- Being multiparous,
- Multiple pregnancies, being in the gestational week less than 20 weeks and greater than 36 weeks,
- Having a diagnosis that constitutes an obstacle to physical activity
About this study
Official title: Assistant Professor,Faculty of Health Sciences Department of Midwifery, Uskudar University, Istanbul, Turkey
Introduction: Today it is seen that women lose their birthing strength, give the control to healthcare personnel during labour and the rate of c-section or interventional labour is increasing. For this reason, the importance of yoga, meditation and breath awareness practices increases during pregnancy and birth. The study was carried out as a randomized control trial with the purpose of examining the impact of yoga and meditation during pregnancy and labour on the labour process.
Methods: The study was completed with 90 primiparous pregnant women in total, 30 in experimental group and 60 in control group. The data was collected using State Trait Anxiety Inventory, Wijma Delivery Expectancy/Experience Questionnaire A, The Childbirth Self-Efficacy Scale Short Form, Wijma Delivery Expectancy/Experience Questionnaire Version B and Visual Analogue Scale. Pregnant women in experimental group did yoga and meditation for 60 minutes 2 times a week for 10 weeks. Innatal period yoga and meditation practices were continued in experimental group during labour.
Read the detailed description
METHODS
Study design:
The present study was conducted as a randomized controlled study. The study was conducted on pregnant women who applied to the pregnancy school of an educational and research hospital on the Anatolian side of Istanbul province between October 2016 and May 2018, and who met the criteria for acceptance of the study.
Setting and samples:
All pregnant women attending the pregnancy school, who agreed to participate in the research, and met the research conditions within the study dates constituted the research population. The sampling of the study was created with the simple random method as the experiment and control group with individuals who met the criteria of the study and who were accepted to participate. In this respect, pregnant women, who were primiparous and between 20-36 gestational weeks, who had single fetuses, expected to give birth normally and spontaneously, with no pregnancy complications and systemic disease, and who could speak Turkish, were included in the study. Power Analysis was made by using the G*Power (v3.1.7) Program to determine the sampling number of the study. According to Cohen's effect size coefficients and other calculations, it was assumed that the evaluations between the two independent groups would have a large impact size (d=0.50). It was also decided that there should be at least 26 people in the groups, and considering that there might be losses in the study process, 30 people were included in the experimental group, and 60 people in the control group, making 90 people in total.
For Randomization, when the experiment and control group were created, support was received from pregnancy school instructors and groups, and pregnant women were determined by using the method of envelope selection. Pregnancy school instructors asked the group volunteering to participate in the study to independently choose one of two blue or red colored envelopes. Those who chose the blue envelope formed the experiment group, and those that chose the red envelope were taken into the control group. The envelope selection process continued until the desired numbers were reached. The researcher was told advised of the groups to which subjects were included by the pregnancy school instructor only after the subjects were chosen.
- Conditions
- Birth, First, Labor Pain, State Anxiety, Self Efficacy
- Being tested
- yoga and meditation, Birth preparation training
- Keywords
- Labour Preparation Class, Labour Support, Meditation, Pregnancy Yoga
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga and meditationBehavioural
The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation.
Birth preparation trainingBehavioural
The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| The Study Group | Experimental | Pregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. Receives: Behavioral: yoga and meditation |
| Control Group | Placebo comparator | The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. Receives: Behavioral: Birth preparation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of Labor (Pregnant)
The Introductory Information Form, which consisted of 8 questions (socio-demographic data) and pregnancy characteristics (12 questions) of pregnant women, and which was prepared in line with the sources, was used.
Measured: 16 hours
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group
The Visual Analog Scale (VAS) consists of a line, often 10 cm long, with verbal anchors at either end, (e.g.,"no pain" on the far left and "the most intense pain imaginable" on the far right). The scale takes a minimum of 0 and a maximum of 10, and higher scores mean a worse result. Visual Analogue Scale (VAS) was used to assess the pains during the birth process of the pregnant women in both the study and control groups.Two ends of the parameter to be evaluated at the two ends of a 100 mm line in VAS the definition is written and the pregnant woman is asked to indicate on this line where her condition is appropriate by drawing a line or putting a dot or pointing. For example, I have no pain at all at one end for pain, very severe pain is written on the other end, and the patient marks his current state on this line. The length of the distance from the place where there is no pain to the place marked by the patient indicates the patient's pain.
Measured: the 4th hour on average after the birth
Secondary outcomes (2)
Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups
the WIJMA Delivery Expectancy/Experience Questionnaire A, was applied once during the study after the 28th week of pregnancy in preparation for childbirth. Wijma Delivery Expectancy/Experience Questionnaire Version B (W-DEQ B) and was applied in the 4th hour on average after the birth event.W-DEQ A: responses on the 33-point scale numbered from 0 to 5 it is a six-bit likert-type scale. 0 is expressed as" completely "and 5 as" never". The minimum score that can be taken from the scale is 0, while the maximum score is 165. High scores indicate that the fear of childbirth experienced by women is high.W-DEQ B: the scale consists of 32 substances. In scale responses are numbered from 0 to 5 and are of six likert type. 0 is expressed as" completely "and 5 as" never". The minimum score on the scale is 0, while the maximum score is 160. As the score increases, the fear of childbirth experienced by women increases.
Measured: the 4th hour on average after the birth
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups
The Childbirth Self-Efficacy Scale Short Form was applied twice as the short form to the study and control group during the study. After the start of birth preparation training, when the pregnant women were in the 28th week, after the application of other forms, it was applied as a pre-test and as a post-test at a time when the pregnant women were appropriate. The lowest score, which can be obtained from the lower dimensions of the scale, is 32, and the highest score is 320 points. A high score to be taken from each lower dimension is related to the birth of pregnant women it shows that the expectation of qualification and results is high. As the scores rise it is determined that it increases self-sufficiency.
Measured: the 4th hour on average after the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Birth, FirstStudies 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
- The present study was conducted as a randomized controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Principal investigator, Tuğba YILMAZ ESENCAN, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883541
- Sponsor's protocol ID
- Uskudar
- Status last verified
- Aug 2021
- First submitted
- 17 Apr 2021
- Last updated
- 9 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Dick-Read G. Childbirth Without Fear: The Principles and Practice of Natural Childbirth. Second edition. UK: Pinter & Martin Ltd; 2013. 56-100.
Rathfisch G. Natural Philosophy of Birth. Istanbul: Nobel Medical Bookstores; 2012.
Öner N, LeCompte A. State Trait Anxiety Inventory Handbook, Istanbul; Boğaziçi University Publications;1983.
Lecompte A, Öner N. A study on the adaptation and standardization of the state-trait anxiety inventory to Turkish. IX. National Psychiatry and Neurological Sciences Congress Studies 1975;457-462.
Erkaya R, Karabulutlu Ö, Çalıka YK. Defining childbirth fear and anxiety levels in pregnant women procedia. Social and Behavioral Sciences 2017; 237:1045-1052.
Gönenç İM, Çakırer-Çalbayram N. Contributions of pregnancy school program, opinions of women on the education and their post-education experiences. Journal of Human Sciences 2017; 14(2), 1609-1620. doi:10.14687/jhs.v14i2.4424.
Çiçek Ö, Okumuş H. Doğumda öz-yeterlilik algisi: önemi ve etkileyen faktörler, Self-Efficacy perception at birth: its importance and effective factors. International Refereed Journal Ofgynaecological Diseases And Maternal Child Health 2017; 35-49.
Greathouse, K. The Nightmare of childbirth: the prevalence and predominant predictor variables for tokophobia in American women of childbearing age [PhD dissertation],. The School of Professional Psychology, Chicago; 2014.
Maharana S, Nagarathna R, Padmalatha V, Nagendra HR, Hankey A. The Effect of Integrated Yoga on Labor Outcome: A Randomized Controlled Study. International Journal of Childbirth 2013;(3):165-77. DOI: 10.1891 / 2156-5287.3.3.165.
Karakuş A, Şahin NH. The attitudes of women toward mode delivery after childbirth. International Journal of Nursing and Midwifery 2011; 3(5): 60-65. https://doi.org/10.5897/IJNM.9000042.
Salomonsson B. Fear is in the air : Midwives´ perspectives of fear of childbirth and childbirth self-efficacy and fear of childbirth in nulliparous pregnant women [PhD dissertation], Linköping University Medical Dissertations, Sweden, 2012; ISBN 978-91-7519-780-7 ISSN 0345-0082.
Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.
PubMed 26656473Simkin P, Bolding A. Update on nonpharmacologic approaches to relieve labor pain and prevent suffering. J Midwifery Womens Health. 2004 Nov-Dec;49(6):489-504. doi: 10.1016/j.jmwh.2004.07.007.
PubMed 15544978Steel A, Adams J, Sibbritt D, Broom A, Frawley J, Gallois C. Relationship between complementary and alternative medicine use and incidence of adverse birth outcomes: an examination of a nationally representative sample of 1835 Australian women. Midwifery. 2014 Dec;30(12):1157-65. doi: 10.1016/j.midw.2014.03.015. Epub 2014 Mar 29.
PubMed 24742636Polis RL, Gussman D, Kuo YH. Yoga in Pregnancy: An Examination of Maternal and Fetal Responses to 26 Yoga Postures. Obstet Gynecol. 2015 Dec;126(6):1237-1241. doi: 10.1097/AOG.0000000000001137.
PubMed 26551176
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor,Faculty of Health Sciences Department of Midwifery, Uskudar University, Istanbul, Turkey
- ClinicalTrials.gov ID
- NCT04883541
- Acronym / sponsor ID
- Uskudar
- Conditions
- Birth, First, Labor Pain, State Anxiety, Self Efficacy
- Keywords
- Labour Preparation Class, Labour Support, Meditation, Pregnancy Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Today it is seen that women lose their birthing strength, give the control to healthcare personnel during labour and the rate of c-section or interventional labour is increasing. For this reason, the importance of yoga, meditation and breath awareness practices increases during pregnancy and birth. The study was carried out as a randomized control trial with the purpose of examining the impact of yoga and meditation during pregnancy and labour on the labour process.
Methods: The study was completed with 90 primiparous pregnant women in total, 30 in experimental group and 60 in control group. The data was collected using State Trait Anxiety Inventory, Wijma Delivery Expectancy/Experience Questionnaire A, The Childbirth Self-Efficacy Scale Short Form, Wijma Delivery Expectancy/Experience Questionnaire Version B and Visual Analogue Scale. Pregnant women in experimental group did yoga and meditation for 60 minutes 2 times a week for 10 weeks. Innatal period yoga and meditation practices were continued in experimental group during labour.
Detailed description
METHODS
Study design:
The present study was conducted as a randomized controlled study. The study was conducted on pregnant women who applied to the pregnancy school of an educational and research hospital on the Anatolian side of Istanbul province between October 2016 and May 2018, and who met the criteria for acceptance of the study.
Setting and samples:
All pregnant women attending the pregnancy school, who agreed to participate in the research, and met the research conditions within the study dates constituted the research population. The sampling of the study was created with the simple random method as the experiment and control group with individuals who met the criteria of the study and who were accepted to participate. In this respect, pregnant women, who were primiparous and between 20-36 gestational weeks, who had single fetuses, expected to give birth normally and spontaneously, with no pregnancy complications and systemic disease, and who could speak Turkish, were included in the study. Power Analysis was made by using the G*Power (v3.1.7) Program to determine the sampling number of the study. According to Cohen's effect size coefficients and other calculations, it was assumed that the evaluations between the two independent groups would have a large impact size (d=0.50). It was also decided that there should be at least 26 people in the groups, and considering that there might be losses in the study process, 30 people were included in the experimental group, and 60 people in the control group, making 90 people in total.
For Randomization, when the experiment and control group were created, support was received from pregnancy school instructors and groups, and pregnant women were determined by using the method of envelope selection. Pregnancy school instructors asked the group volunteering to participate in the study to independently choose one of two blue or red colored envelopes. Those who chose the blue envelope formed the experiment group, and those that chose the red envelope were taken into the control group. The envelope selection process continued until the desired numbers were reached. The researcher was told advised of the groups to which subjects were included by the pregnancy school instructor only after the subjects were chosen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study was conducted as a randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| The Study Group | Experimental | Behavioral: yoga and meditationPregnant women participated in the applications, which lasted two days a week, for ten weeks, and for 60 minutes a day. |
| Control Group | Placebo comparator | Behavioral: Birth preparation trainingThe control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women,
- Primiparous and between 20-36 gestational weeks,
- Single fetuses, expected to give birth normally and spontaneously,
- No pregnancy complications and systemic disease,
- Speak Turkish
Key exclusion criteria (7 listed)
- Being unable to speak Turkish
- Having a history of serious illness that threatens life or because of these reasons.
- Currently or previously due to a serious mental weakness or illness
- Being diagnosed with a psychiatric diagnosis and being treated for this reason,
- Being multiparous,
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 |
|---|---|---|
| yoga and meditationThe pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation. | Behavioural | The Study Group |
| Birth preparation trainingThe control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups. | Behavioural | Control Group |
Primary outcome
Characteristics of Labor (Pregnant)
Time frame: 16 hours
The Introductory Information Form, which consisted of 8 questions (socio-demographic data) and pregnancy characteristics (12 questions) of pregnant women, and which was prepared in line with the sources, was used.
Comparison of Visual Analog Scale (Pain) Scores of Pregnant Women in Study and Control Group
Time frame: the 4th hour on average after the birth
The Visual Analog Scale (VAS) consists of a line, often 10 cm long, with verbal anchors at either end, (e.g.,"no pain" on the far left and "the most intense pain imaginable" on the far right). The scale takes a minimum of 0 and a maximum of 10, and higher scores mean a worse result. Visual Analogue Scale (VAS) was used to assess the pains during the birth process of the pregnant women in both the study and control groups.Two ends of the parameter to be evaluated at the two ends of a 100 mm line in VAS the definition is written and the pregnant woman is asked to indicate on this line where her condition is appropriate by drawing a line or putting a dot or pointing. For example, I have no pain at all at one end for pain, very severe pain is written on the other end, and the patient marks his current state on this line. The length of the distance from the place where there is no pain to the place marked by the patient indicates the patient's pain.
2 secondary outcomes
Comparison of WIJMAA and WIJMAB Average Scores of Pregnant Women in the Study and Control Groups
Time frame: the 4th hour on average after the birth
Comparison of Average Self-sufficiency Scores of Pregnant Women in the Study and Control Groups
Time frame: the 4th hour on average after the birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundDick-Read G. Childbirth Without Fear: The Principles and Practice of Natural Childbirth. Second edition. UK: Pinter & Martin Ltd; 2013. 56-100.
- BackgroundRathfisch G. Natural Philosophy of Birth. Istanbul: Nobel Medical Bookstores; 2012.
- BackgroundÖner N, LeCompte A. State Trait Anxiety Inventory Handbook, Istanbul; Boğaziçi University Publications;1983.
- BackgroundLecompte A, Öner N. A study on the adaptation and standardization of the state-trait anxiety inventory to Turkish. IX. National Psychiatry and Neurological Sciences Congress Studies 1975;457-462.
- BackgroundErkaya R, Karabulutlu Ö, Çalıka YK. Defining childbirth fear and anxiety levels in pregnant women procedia. Social and Behavioral Sciences 2017; 237:1045-1052.
- BackgroundGönenç İM, Çakırer-Çalbayram N. Contributions of pregnancy school program, opinions of women on the education and their post-education experiences. Journal of Human Sciences 2017; 14(2), 1609-1620. doi:10.14687/jhs.v14i2.4424.
- BackgroundÇiçek Ö, Okumuş H. Doğumda öz-yeterlilik algisi: önemi ve etkileyen faktörler, Self-Efficacy perception at birth: its importance and effective factors. International Refereed Journal Ofgynaecological Diseases And Maternal Child Health 2017; 35-49.
- BackgroundGreathouse, K. The Nightmare of childbirth: the prevalence and predominant predictor variables for tokophobia in American women of childbearing age [PhD dissertation],. The School of Professional Psychology, Chicago; 2014.
- BackgroundMaharana S, Nagarathna R, Padmalatha V, Nagendra HR, Hankey A. The Effect of Integrated Yoga on Labor Outcome: A Randomized Controlled Study. International Journal of Childbirth 2013;(3):165-77. DOI: 10.1891 / 2156-5287.3.3.165.
- BackgroundKarakuş A, Şahin NH. The attitudes of women toward mode delivery after childbirth. International Journal of Nursing and Midwifery 2011; 3(5): 60-65. https://doi.org/10.5897/IJNM.9000042.
- BackgroundSalomonsson B. Fear is in the air : Midwives´ perspectives of fear of childbirth and childbirth self-efficacy and fear of childbirth in nulliparous pregnant women [PhD dissertation], Linköping University Medical Dissertations, Sweden, 2012; ISBN 978-91-7519-780-7 ISSN 0345-0082.
- Results publication: PubMed 26656473Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.
- Akarsu RH. The effect of pregnancy yoga on the psychosocial health level of pregnant women and prenatal attachment \[PhD dissertation\],. T.C. Istanbul University, Institute of Health Sciences, Department of Women's Health and Diseases Nursing, WomenLink provided by the sponsor.
- Esencan TY, Karabulut Ö, Yıldırım AD, Abbasoğlu DE, Külek H. et. al. Type of delivery, time of ınitial breastfeeding, and skin-to-skin contact of pregnant women participating in childbirth preparation education. Florence Nightingale Journal of NursiLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Questions about this trial
What is this clinical trial studying?
A study testing yoga and meditation and Birth preparation training in people with Birth, First and Labor Pain, run by Uskudar 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 5 inclusion and 7 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 9 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Characteristics of Labor (Pregnant) (time frame: 16 hours). 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?
On the ClinicalTrials.gov record for NCT04883541, which also lists 31 linked publications.
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 Aug 2021.