Impact of Medjool Date Consumption on Labor and Delivery Outcomes

NCT07058792 | Recruiting

• 1 other identifier: 25-059
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spontaneous Labor

Keywords

Medjool dates

Outcome Measures

Primary Outcomes (1)

• 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.

  13 weeks

Study Arms (2)

Dates consumption group

EXPERIMENTAL

Subjects will eat dates in addition to routine care

Other: Medjool dates

No dates group

NO INTERVENTION

Subjects will receive routine care only.

Interventions

Medjool dates OTHER

Medjool dates are a dried fruit.

Dates consumption group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biologically female participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Incomplete delivery data
• Planned cesarean delivery
• Planned induction of labor prior to 41 weeks

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Stacey Ehrenberg, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Easha Patel, M.D.

CONTACT

216-695-5383; patele@ccf.org

Stacey Ehrenberg, M.D.

CONTACT

216-618-7235; ehrenbs@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive dates and one group will receive routine care.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 10, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)