Yumi DatesMedjool Date Consumption Impact on Labor and Delivery
This study looks at how eating Medjool dates affects labor and delivery. We'll observe and record the number of spontaneous labors in participants.
Medjool dates
Other Study
Summary
Study start date: February 21, 2025
Actual date on which the first participant was enrolled.This study investigates whether eating Medjool dates starting from the 34th week of pregnancy can influence labor and delivery outcomes. Pregnant individuals will be divided into two groups: one consuming dates daily until delivery, and the other following standard care without dates. The focus is on whether eating dates affects the likelihood of spontaneous labor or reduces the need for labor induction. This research could provide valuable insights into natural dietary interventions for pregnant individuals aiming for smoother delivery processes. Participants in the study will consume three Medjool dates daily from the 34th week of their pregnancy until the day after delivery if they are in the dates group. Additionally, they will have a glucose check one hour after eating dates on the day of delivery. Participants will also keep track of their food intake through electronic diaries at specified intervals. Data collected from these diaries, along with other medical records, will help researchers evaluate the influence of Medjool date consumption on labor. The study aims to include up to 250 participants and ensure all data is securely stored and only accessible to the study team.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * 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 Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location