Maternal OutcomesNCT06670235
Effectiveness of Upright vs. Lithotomy Birthing Position on Maternal and Newborn Outcomes
A study testing Upright Birthing Position and Lithotomy Birthing Position in people with Maternal Outcomes and Newborn Complication, run by Hawler Medical University at 1 site in Iraq.
Trial summary
This study investigates the effectiveness of upright versus lithotomy birthing positions on maternal and newborn outcomes. Conducted at the Maternity Teaching Hospital in Erbil City, it employs a quasi-experimental design with 62 women in each group (Intervention and control), comparing outcomes for those encouraged… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Outcomes, Newborn Complication
- What is being tested?
- Upright Birthing Position and Lithotomy Birthing Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIraq
- Study dates
- 10 Nov 2024to 1 Sep 2026
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women with singleton pregnancies;
- Gestational age ranges from (≥37 to 41+6 weeks);
- Spontaneous labor with no contraindications to upright positions;
- Active phase of first stage labor;
- Age 18-35 years old;
- Normal size fetus with occipito-anterior position;
- Communicate normally and participate voluntary.
Who cannot join
- Abnormal fetal position (malpresentation) (e,g., persistent occipital-transverse and occipital-posterior position, etc.);
- Risky pregnancy or childbirth complications, such as (preeclampsia, eclampsia, heart disease, cephalic presentation dystocia, antepartum hemorrhage, fetal distress, intra-uterine growth restriction, intra-amniotic infection); and free from any chronic diseases (heart disease, epilepsy, hypertension, diabetes mellitus and renal disease)
- Multiple gestation;
- Cephalopelvic disproportion (CPD);
- Precipitate labor;
- Antenatally diagnosed fetal anomalies;
- Current history of a leg injury, fracture, and deep vein thrombosis.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Hawler Medical University, Erbil, Kurdistan region 44001
Erbil, 44001
Zhian Mahmoud Dezayee, professor, 0662273383, zhian.dezayee@hmu.edu.krd
Wahida Abdullah Ibrahim, Master
About this study
Official title: Effectiveness of Using Upright Versus Lithotomy Birthing Position on Maternal and Newborn Outcomes: A Quasi Experimental Study
This study investigates the effectiveness of upright versus lithotomy birthing positions on maternal and newborn outcomes. Conducted at the Maternity Teaching Hospital in Erbil City, it employs a quasi-experimental design with 62 women in each group (Intervention and control), comparing outcomes for those encouraged to use upright positions with those in standard lithotomy. Maternal and newborn outcomes will be assessed to provide evidence on how birthing positions impact labor progression, comfort, and delivery results. The findings aim to inform clinical practice and policy, enhancing midwifery care and supporting patient-centered approaches to childbirth. Does the upright birthing position effect on maternal and newborn outcomes? Does the lithotomy birthing position effect on maternal and newborn outcomes? The expected outcomes will decrease the rate of perineal tear , episiotomy , post partum hemorrhage and decreasing the rate of admission to Neonatal Intensive Care Unit (NICU) in newborn.
Read the detailed description
This quasi-experimental study assesses the impact of upright versus lithotomy birthing positions on maternal and newborn outcomes, aiming to contribute evidence-based recommendations for optimal birthing practices. As childbirth management increasingly prioritizes maternal comfort and positive birth experiences, this research seeks to fill gaps in understanding the clinical efficacy and maternal satisfaction associated with each position.
Conducted at the Maternity Teaching Hospital in Erbil City, the study will recruit 124 pregnant women, divided equally into two groups: one encouraged to adopt upright positions (e.g., squatting) during labor and delivery, and the other following standard lithotomy position practices. A non probability convenience sampling method is employed, with participants meeting specific inclusion criteria such as gestational age, health status, and labor progression factors.
The intervention includes the promotion of upright positions in the experimental group, while both groups receive standardized maternal care. Data on maternal outcomes-such as labor duration, pain levels, and delivery type-and newborn outcomes, including Apgar scores and need for resuscitation, will be collected and analyzed pre- and post-intervention.
The study's goal is to identify whether upright positions correlate with enhanced labor outcomes, reduced intervention rates, and increased maternal satisfaction. Findings are expected to guide clinical guidelines, informing both practitioners and patients on effective, patient-centered birthing positions. This research further aims to influence midwifery education and policy, advocating for practices that align with women's preferences and cultural contexts, ultimately enhancing maternal and neonatal health outcomes through evidence-based childbirth management.
- Conditions
- Maternal Outcomes, Newborn Complication
- Being tested
- Upright Birthing Position, Lithotomy Birthing Position
- Keywords
- Upright birthing position, Lithotomy position, Maternal outcomes in childbirth, Newborn outcomes in labor, Birth position comparison, Labor positions and delivery, Effectiveness of birth positions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upright Birthing PositionBehavioural
This intervention involves encouraging participants to use an upright position during labor and delivery, which may include : squatting, based on their preference and comfort level. Healthcare staff will support the participants in maintaining an upright position throughout labor as much as possible to evaluate its effects on maternal and newborn outcomes.
Lithotomy Birthing PositionBehavioural
Participants in this arm will be positioned in the lithotomy position during labor and delivery, which is a common practice in clinical settings. In this position, the mother lies on her back with her legs supported in stirrups. This intervention serves as the control condition to provide a baseline comparison for evaluating outcomes against the upright birthing position.
| Study group | Role | What they receive |
|---|---|---|
| Upright Birthing Position Group | Experimental | Participants assigned to the Upright Birthing Position Arm will be encouraged to maintain an upright position during labor and delivery. The upright position includes a squatting. This arm aims to assess the potential benefits of the upright position, such as improved maternal outcomes (e.g., shorter labor duration, reduced need for interventions) and favorable newborn outcomes (e.g., higher Apgar scores, better oxygenation).
To evaluate the effects of upright positioning on both maternal and newborn outcomes compared to the traditional lithotomy position. Receives: Behavioral: Upright Birthing Position |
| Lithotomy Birthing Position | Active comparator | Participants in the Lithotomy Position Arm will follow the standard hospital practice of delivering in the lithotomy position, where the mother is lying on her back with legs supported in stirrups. This position is widely used in clinical settings and serves as the control arm to compare with the outcomes from the upright birthing position.
To serve as a control group to provide a comparative measure of maternal and newborn outcomes against the upright birthing position. Outcomes will include maternal comfort, labor duration, intervention requirements, and newborn health indicators. Receives: Behavioral: Lithotomy Birthing Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Labor Duration
The total time from the onset of active labor until delivery. Measurement Method: Measured in minutes and seconds recording by using the stopwatch from mobile clock.
Measured: Assessed continuously from the onset of active labor until delivery.
Newborn Apgar score
Apgar score at 1 , 5 and 10 minutes post-delivery, Measurement Method: from 0 to 2, with a maximum total score of 10, (Color, Heart rate, Reflex, Muscle Tone, Breath).
Total Score Interpretation 7-10: Generally normal; baby is likely to be in good health. 4-6: Intermediate; may need some help with breathing or other care. 0-3: Critical; immediate resuscitative efforts are typically required.
Measured: Immediately after delivery , Assessed at 1 minute , 5 minutes and 10 minutes post-delivery
Secondary outcomes (3)
Maternal Perception of Pain and Comfort
Maternal self-reported pain level and comfort during labor and delivery, Measurement Method: Visual Analog Scale (VAS) for pain; Likert scale for comfort. A 0 to 10 Likert scale for pain perception provides more granularity and allows patients to more precisely indicate their pain level. Higher scores generally indicate worse outcomes, meaning more intense pain.
Lower scores indicate better outcomes or less pain. 0 - No Pain
1 to 3 - Mild Pain: Minimal discomfort . 4 to 6 - Moderate Pain 7 to 9 - Severe Pain 10 - Worst Possible Pain
Measured: Assessed during labor (intervals to be specified, e.g., every 2 hours) and immediately after delivery.
Postpartum Hemorrhage (PPH)
Estimated blood loss during and after delivery. Measurement methods estimation by (measured in milliliters). Measuring blood loss after labor and delivery is critical in assessing maternal health and identifying postpartum hemorrhage (PPH), a leading cause of maternal mortality. Here are common methods for measuring blood loss in a clinical setting: Traditionally, healthcare providers visually assess blood loss by observing and estimating the amount of blood in pads, towels, drapes, and other materials.
Though commonly used, visual estimation is often inaccurate, tending to underestimate actual blood loss.
Less than 500 ml is indicated normal and more than 500 ml Indicate severe blood loss or significant intervention needs, signaling a worse outcome and potentially requiring immediate medical action.
Measured: Estimated immediately following delivery and up to 2 hours postpartum.
Maternal Satisfaction with the Birth Experience
Maternal satisfaction with the birth experience is a crucial indicator of quality in maternity care, reflecting the mother's perceptions, emotions, and overall satisfaction with the care received during labor and delivery. A positive birth experience can enhance maternal confidence, strengthen the mother-infant bond, and promote mental health, while a negative experience may contribute to postpartum depression, anxiety, and even trauma.
Measuring Maternal Satisfaction Maternal satisfaction is often assessed using validated questionnaires, such as the Childbirth Experience Questionnaire (CEQ) by using this items : Highly Dissatisfied, Dissatisfied, Neutral, Satisfied, Highly Satisfied with good outcomes is highly satisfied but bad outcomes is highly dissatisfied.
Measured: Assessed within the first 2 hours postpartum, typically before hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion25 Oct 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Maternal OutcomesStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WAHIDA ABDULLAH IBRAHIM, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670235
- Sponsor's protocol ID
- Birth Position
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Huang S, Guo X, Zhao N, Lu Y, Chen M, Li Y, Wu J, Huang L, Ma F, Yang Y, Zhang X, Zhou X, Guo R, Cai W. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China. Midwifery. 2017 Jul;50:117-124. doi: 10.1016/j.midw.2017.03.022. Epub 2017 Mar 31.
PubMed 28414983Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, Ashby D, Emsley R, Fergusson DA, Walters SJ, Wilson ECF, Maclennan G, Stallard N, Rothwell JC, Bland M, Brown L, Ramsay CR, Cook A, Armstrong D, Altman D, Vale LD. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials. 2018 Nov 5;19(1):606. doi: 10.1186/s13063-018-2884-0.
PubMed 30400926Fu L, Huang J, Li D, Wang H, Xing L, Wei T, Hou R, Lu H. Effects of Using Sitting Position versus Lithotomy Position during the Second Stage of Labour on Maternal and Neonatal Outcomes and the Childbirth Experience of Chinese Women: A Prospective Cohort Study. Healthcare (Basel). 2023 Nov 20;11(22):2996. doi: 10.3390/healthcare11222996.
PubMed 37998488Elvander C, Ahlberg M, Thies-Lagergren L, Cnattingius S, Stephansson O. Birth position and obstetric anal sphincter injury: a population-based study of 113 000 spontaneous births. BMC Pregnancy Childbirth. 2015 Oct 9;15:252. doi: 10.1186/s12884-015-0689-7.
PubMed 26453177Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.
PubMed 24762366
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Upright Versus Lithotomy Birthing Position on Maternal and Newborn Outcomes: A Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT06670235
- Acronym / sponsor ID
- Birth Position
- Conditions
- Maternal Outcomes, Newborn Complication
- Keywords
- Upright birthing position, Lithotomy position, Maternal outcomes in childbirth, Newborn outcomes in labor, Birth position comparison, Labor positions and delivery, Effectiveness of birth positions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 1 Nov 2024 (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.
This study investigates the effectiveness of upright versus lithotomy birthing positions on maternal and newborn outcomes. Conducted at the Maternity Teaching Hospital in Erbil City, it employs a quasi-experimental design with 62 women in each group (Intervention and control), comparing outcomes for those encouraged to use upright positions with those in standard lithotomy. Maternal and newborn outcomes will be assessed to provide evidence on how birthing positions impact labor progression, comfort, and delivery results. The findings aim to inform clinical practice and policy, enhancing midwifery care and supporting patient-centered approaches to childbirth. Does the upright birthing position effect on maternal and newborn outcomes? Does the lithotomy birthing position effect on maternal and newborn outcomes? The expected outcomes will decrease the rate of perineal tear , episiotomy , post partum hemorrhage and decreasing the rate of admission to Neonatal Intensive Care Unit (NICU) in newborn.
Detailed description
This quasi-experimental study assesses the impact of upright versus lithotomy birthing positions on maternal and newborn outcomes, aiming to contribute evidence-based recommendations for optimal birthing practices. As childbirth management increasingly prioritizes maternal comfort and positive birth experiences, this research seeks to fill gaps in understanding the clinical efficacy and maternal satisfaction associated with each position.
Conducted at the Maternity Teaching Hospital in Erbil City, the study will recruit 124 pregnant women, divided equally into two groups: one encouraged to adopt upright positions (e.g., squatting) during labor and delivery, and the other following standard lithotomy position practices. A non probability convenience sampling method is employed, with participants meeting specific inclusion criteria such as gestational age, health status, and labor progression factors.
The intervention includes the promotion of upright positions in the experimental group, while both groups receive standardized maternal care. Data on maternal outcomes-such as labor duration, pain levels, and delivery type-and newborn outcomes, including Apgar scores and need for resuscitation, will be collected and analyzed pre- and post-intervention.
The study's goal is to identify whether upright positions correlate with enhanced labor outcomes, reduced intervention rates, and increased maternal satisfaction. Findings are expected to guide clinical guidelines, informing both practitioners and patients on effective, patient-centered birthing positions. This research further aims to influence midwifery education and policy, advocating for practices that align with women's preferences and cultural contexts, ultimately enhancing maternal and neonatal health outcomes through evidence-based childbirth management.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upright Birthing Position Group | Experimental | Behavioral: Upright Birthing PositionParticipants assigned to the Upright Birthing Position Arm will be encouraged to maintain an upright position during labor and delivery. The upright position includes a squatting. This arm aims to assess the potential benefits of the upright position, such as improved maternal outcomes (e.g., shorter labor duration, reduced need for interventions) and favorable newborn outcomes (e.g., higher Apgar scores, better oxygenation). To evaluate the effects of upright positioning on both maternal and newborn outcomes compared to the traditional lithotomy position. |
| Lithotomy Birthing Position | Active comparator | Behavioral: Lithotomy Birthing PositionParticipants in the Lithotomy Position Arm will follow the standard hospital practice of delivering in the lithotomy position, where the mother is lying on her back with legs supported in stirrups. This position is widely used in clinical settings and serves as the control arm to compare with the outcomes from the upright birthing position. To serve as a control group to provide a comparative measure of maternal and newborn outcomes against the upright birthing position. Outcomes will include maternal comfort, labor duration, intervention requirements, and newborn health indicators. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women with singleton pregnancies;
- Gestational age ranges from (≥37 to 41+6 weeks);
- Spontaneous labor with no contraindications to upright positions;
- Active phase of first stage labor;
- Age 18-35 years old;
Key exclusion criteria (7 listed)
- Abnormal fetal position (malpresentation) (e,g., persistent occipital-transverse and occipital-posterior position, etc.);
- Risky pregnancy or childbirth complications, such as (preeclampsia, eclampsia, heart disease, cephalic presentation dystocia, antepartum hemorrhage, fetal distress, intra-uterine growth restriction, intra-amniotic infection); and free from any chronic diseases (heart disease, epilepsy, hypertension, diabetes mellitus and renal disease)
- Multiple gestation;
- Cephalopelvic disproportion (CPD);
- Precipitate labor;
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 |
|---|---|---|
| Upright Birthing PositionThis intervention involves encouraging participants to use an upright position during labor and delivery, which may include : squatting, based on their preference and comfort level. Healthcare staff will support the participants in maintaining an upright position throughout labor as much as possible to evaluate its effects on maternal and newborn outcomes. | Behavioural | Upright Birthing Position Group |
| Lithotomy Birthing PositionParticipants in this arm will be positioned in the lithotomy position during labor and delivery, which is a common practice in clinical settings. In this position, the mother lies on her back with her legs supported in stirrups. This intervention serves as the control condition to provide a baseline comparison for evaluating outcomes against the upright birthing position. | Behavioural | Lithotomy Birthing Position |
Primary outcome
Maternal Labor Duration
Time frame: Assessed continuously from the onset of active labor until delivery.
The total time from the onset of active labor until delivery. Measurement Method: Measured in minutes and seconds recording by using the stopwatch from mobile clock.
Newborn Apgar score
Time frame: Immediately after delivery , Assessed at 1 minute , 5 minutes and 10 minutes post-delivery
Apgar score at 1 , 5 and 10 minutes post-delivery, Measurement Method: from 0 to 2, with a maximum total score of 10, (Color, Heart rate, Reflex, Muscle Tone, Breath). Total Score Interpretation 7-10: Generally normal; baby is likely to be in good health. 4-6: Intermediate; may need some help with breathing or other care. 0-3: Critical; immediate resuscitative efforts are typically required.
3 secondary outcomes
Maternal Perception of Pain and Comfort
Time frame: Assessed during labor (intervals to be specified, e.g., every 2 hours) and immediately after delivery.
Postpartum Hemorrhage (PPH)
Time frame: Estimated immediately following delivery and up to 2 hours postpartum.
Maternal Satisfaction with the Birth Experience
Time frame: Assessed within the first 2 hours postpartum, typically before hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 28414983Zhang H, Huang S, Guo X, Zhao N, Lu Y, Chen M, Li Y, Wu J, Huang L, Ma F, Yang Y, Zhang X, Zhou X, Guo R, Cai W. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China. Midwifery. 2017 Jul;50:117-124. doi: 10.1016/j.midw.2017.03.022. Epub 2017 Mar 31.
- Background: PubMed 30400926Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, Ashby D, Emsley R, Fergusson DA, Walters SJ, Wilson ECF, Maclennan G, Stallard N, Rothwell JC, Bland M, Brown L, Ramsay CR, Cook A, Armstrong D, Altman D, Vale LD. DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. Trials. 2018 Nov 5;19(1):606. doi: 10.1186/s13063-018-2884-0.
- Background: PubMed 37998488Fu L, Huang J, Li D, Wang H, Xing L, Wei T, Hou R, Lu H. Effects of Using Sitting Position versus Lithotomy Position during the Second Stage of Labour on Maternal and Neonatal Outcomes and the Childbirth Experience of Chinese Women: A Prospective Cohort Study. Healthcare (Basel). 2023 Nov 20;11(22):2996. doi: 10.3390/healthcare11222996.
- Background: PubMed 26453177Elvander C, Ahlberg M, Thies-Lagergren L, Cnattingius S, Stephansson O. Birth position and obstetric anal sphincter injury: a population-based study of 113 000 spontaneous births. BMC Pregnancy Childbirth. 2015 Oct 9;15:252. doi: 10.1186/s12884-015-0689-7.
- Background: PubMed 24762366Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upright Birthing Position and Lithotomy Birthing Position in people with Maternal Outcomes and Newborn Complication, run by Hawler Medical University at 1 site in Iraq.
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 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. 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 Iraq. 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 Wahida Ibrahim, Master (009647509663311, Wahida.ibraheem@hmu.edu.krd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Labor Duration (time frame: Assessed continuously from the onset of active labor until delivery.). 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 NCT06670235, which also lists 5 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 1 Nov 2024.