RecruitingNot ApplicableNCT07058792

Impact of Medjool Date Consumption on Labor and Delivery Outcomes


Sponsor

The Cleveland Clinic

Enrollment

250 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria9

  • 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

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Interventions

OTHERMedjool dates

Medjool dates are a dried fruit.


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

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NCT07058792