Impact of Medjool Date Consumption on Labor and Delivery Outcomes (Yumi Dates)

NeuroTherapia, Inc.

Status

Enrolling

Conditions

Spontaneous Labor

Treatments

Other: Medjool dates

Study type

Interventional

Funder types

Other

Identifiers

NCT07058792

25-059

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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