Impact of Medjool Date Consumption on Labor and Delivery Outcomes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07058792
Status
Recruiting
Apply to this trial

Conditions

  • Spontaneous Labor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medjool dates — OTHER
    Medjool dates are a dried fruit.

Study Details

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.

Key Dates

Start date
Feb 21, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Dates consumption group
    Subjects will eat dates in addition to routine care
  • No Intervention: No dates group
    Subjects will receive routine care only.

Primary Outcome Measure

Incidence of spontaneous labor [ Time Frame: 13 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Stacey Ehrenberg, M.D.
[email protected]
216-618-7235
Easha Patel, M.D.
[email protected]
216-695-5383
Stacey Ehrenberg, M.D. (PRINCIPAL_INVESTIGATOR)

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Cleveland Clinic· Cleveland, OH