Spontaneous LaborYumi DatesNCT07058792
Impact of Medjool Date Consumption on Labor and Delivery Outcomes
A study testing Medjool dates in people with Spontaneous Labor, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The proposed Medjool date randomized trial will help inform clinical practice regarding the utility of Medjool date consumption for labor onset by comparing the incidence of spontaneous labor with the need for labor induction in patients who have been randomized to consume Medjool dates from 34 weeks gestation through… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spontaneous Labor
- What is being tested?
- Medjool dates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 13 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy less than 36weeks 0 days gestational age
- Age ≥18 years old
- Has decision-making capacity and able to provide informed consent for research participation
- Able to speak, read and understand English
- Planned delivery at a Cleveland Clinic Institution
Who cannot join
- Pre-existing medical co-morbidities including hypertension, kidney disease, autoimmune conditions, diabetes
- Comorbidities of pregnancy including hypertensive disorders of pregnancy and gestational diabetes
- Abnormal genetic (aneuploidy) screening or diagnostic testing
- Patients with pregnancies complicated by major fetal anomalies
- Multifetal gestation
- Delivery at an outside institution
Show all 9Show fewer
- Incomplete delivery data
- Planned cesarean delivery
- Planned induction of labor prior to 41 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The proposed Medjool date randomized trial will help inform clinical practice regarding the utility of Medjool date consumption for labor onset by comparing the incidence of spontaneous labor with the need for labor induction in patients who have been randomized to consume Medjool dates from 34 weeks gestation through the day after delivery day. The study will secondarily investigate the relationship between date consumption and other important labor and delivery outcomes such as length of labor, need for oxytocin, dose of oxytocin and quantitative blood loss at delivery. This study will also explore the association between Medjool date consumption, perinatal hemoglobin levels, and perinatal diet quality. Assessing dietary intake is an essential component of this study to better understand the relationship between medjool date consumption and pregnancy/labor outcomes by controlling for it as a potential confounding factor. Furthermore, assessing dietary intake will provide insight on the impact medjool date consumption has on overall maternal diet quality.
Read the detailed description
The study is a randomized controlled trial evaluating labor outcomes for pregnant patients who begin Medjool date consumption during the 34th week of pregnancy versus those who do not consume dates prior to labor. We aim to assess whether Medjool date consumption impacts labor and delivery outcomes, specifically incidence of spontaneous labor compared with need for labor induction.
Patients will be screened and recruited at their routine prenatal appointment prior to 34 weeks. Eligible patients who desire participation after a discussion of the potential risks/benefits of participation will be consented and enrolled into this randomized control trial. They will randomized into either the Standard Care/No Dates group or the Dates group during this initial visit.
Patients randomized to the Dates group will be provided 42 pre-portioned bags of Medjool dates and instructed to eat 3 dates a day from 34 weeks of pregnancy until delivery as well as 3 dates on the day of delivery and 3 dates on the day after delivery. They will additionally have a point-of-care glucose check one hour consuming dates on the day of delivery. Patient will have daily surveys administered via REDCap to document their date intake prior to their delivery admission.
All patients in the study will also be completing food diaries through a 3-day electronic diet records for two time points during the study. The diet records will be electronic and collected using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. ASA24 is a validated, web-based dietary assessment tool developed by the National Cancer Institute for research purposes. The two time points for the diet records are 3 days prior to 34 weeks pregnancy and 3 days after 34 weeks of pregnancy. Patient will receive unique login information to complete the dietary records on the ASA24 website.
Data will be abstracted from the electronic medical record and stored in a password protected REDCap database only available to the study team. Dietary data will be collected through the National Cancer Institute's ASA24 research-based dietary assessment tool.
The researchers aim to recruit up to 250 patients at the study institution.
- Conditions
- Spontaneous Labor
- Being tested
- Medjool dates
- Keywords
- Medjool dates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medjool datesOther
Medjool dates are a dried fruit.
| Study group | Role | What they receive |
|---|---|---|
| Dates consumption group | Experimental | Subjects will eat dates in addition to routine care Receives: Other: Medjool dates |
| No dates group | No intervention | Subjects will receive routine care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spontaneous labor
This is a clinical diagnosis. Labor is defined as regular uterine contractions with cervical change. This will be documented in the medical record by the clinical provider.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start21 Feb 2025
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous LaborStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive dates and one group will receive routine care.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey Ehrenberg, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058792
- Sponsor's protocol ID
- 25-059
- Acronym
- Yumi Dates
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to make IPD public.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medjool Date Consumption on Labor and Delivery Outcomes
- ClinicalTrials.gov ID
- NCT07058792
- Acronym / sponsor ID
- Yumi Dates / 25-059
- Conditions
- Spontaneous Labor
- Keywords
- Medjool dates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 10 Jul 2025 (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.
The proposed Medjool date randomized trial will help inform clinical practice regarding the utility of Medjool date consumption for labor onset by comparing the incidence of spontaneous labor with the need for labor induction in patients who have been randomized to consume Medjool dates from 34 weeks gestation through the day after delivery day. The study will secondarily investigate the relationship between date consumption and other important labor and delivery outcomes such as length of labor, need for oxytocin, dose of oxytocin and quantitative blood loss at delivery. This study will also explore the association between Medjool date consumption, perinatal hemoglobin levels, and perinatal diet quality. Assessing dietary intake is an essential component of this study to better understand the relationship between medjool date consumption and pregnancy/labor outcomes by controlling for it as a potential confounding factor. Furthermore, assessing dietary intake will provide insight on the impact medjool date consumption has on overall maternal diet quality.
Detailed description
The study is a randomized controlled trial evaluating labor outcomes for pregnant patients who begin Medjool date consumption during the 34th week of pregnancy versus those who do not consume dates prior to labor. We aim to assess whether Medjool date consumption impacts labor and delivery outcomes, specifically incidence of spontaneous labor compared with need for labor induction.
Patients will be screened and recruited at their routine prenatal appointment prior to 34 weeks. Eligible patients who desire participation after a discussion of the potential risks/benefits of participation will be consented and enrolled into this randomized control trial. They will randomized into either the Standard Care/No Dates group or the Dates group during this initial visit.
Patients randomized to the Dates group will be provided 42 pre-portioned bags of Medjool dates and instructed to eat 3 dates a day from 34 weeks of pregnancy until delivery as well as 3 dates on the day of delivery and 3 dates on the day after delivery. They will additionally have a point-of-care glucose check one hour consuming dates on the day of delivery. Patient will have daily surveys administered via REDCap to document their date intake prior to their delivery admission.
All patients in the study will also be completing food diaries through a 3-day electronic diet records for two time points during the study. The diet records will be electronic and collected using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. ASA24 is a validated, web-based dietary assessment tool developed by the National Cancer Institute for research purposes. The two time points for the diet records are 3 days prior to 34 weeks pregnancy and 3 days after 34 weeks of pregnancy. Patient will receive unique login information to complete the dietary records on the ASA24 website.
Data will be abstracted from the electronic medical record and stored in a password protected REDCap database only available to the study team. Dietary data will be collected through the National Cancer Institute's ASA24 research-based dietary assessment tool.
The researchers aim to recruit up to 250 patients at the study institution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive dates and one group will receive routine care.
| Arm | Type | Receives |
|---|---|---|
| Dates consumption group | Experimental | Other: Medjool datesSubjects will eat dates in addition to routine care |
| No dates group | No intervention | –Subjects will receive routine care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton pregnancy less than 36weeks 0 days gestational age
- Age ≥18 years old
- Has decision-making capacity and able to provide informed consent for research participation
- Able to speak, read and understand English
- Planned delivery at a Cleveland Clinic Institution
Key exclusion criteria (9 listed)
- Pre-existing medical co-morbidities including hypertension, kidney disease, autoimmune conditions, diabetes
- Comorbidities of pregnancy including hypertensive disorders of pregnancy and gestational diabetes
- Abnormal genetic (aneuploidy) screening or diagnostic testing
- Patients with pregnancies complicated by major fetal anomalies
- Multifetal gestation
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 |
|---|---|---|
| Medjool datesMedjool dates are a dried fruit. | Other | Dates consumption group |
Primary outcome
Incidence of spontaneous labor
Time frame: 13 weeks
This is a clinical diagnosis. Labor is defined as regular uterine contractions with cervical change. This will be documented in the medical record by the clinical provider.
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 3 Aug 2026.
- Individual participant dataSharing planned: No. No plans to make IPD public.
Related trials for Spontaneous Labor
Not yet recruitingObservational study
Cervical Length Reference Range at 28-34 Weeks in Singleton Pregnancies
Preterm Birth, Cervical Length
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Not yet recruiting
High-Flow Tracheal Oxygen During Spontaneous Breathing Trial
Mechanical Ventilation Weaning, Spontaneous Breathing Trial
Not yet recruiting
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
Preterm Birth Complication, Preterm Birth
Not yet recruitingObservational study
Cohort Study on the Levels of Placental Growth Factor and Nucleosomes in Early Pregnancy and Adverse Pregnancy Outcomes
Preeclampsia, Premature Birth
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.
Stacey Ehrenberg, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medjool dates in people with Spontaneous Labor, run by The Cleveland Clinic at 1 site in United States.
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 9 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 3 Aug 2026. 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 United States. 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?
Incidence of spontaneous labor (time frame: 13 weeks). 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 3 Aug 2026.