The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy

February 29, 2024 updated by: Halime Esra Meram, Selcuk University

The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy on The First Stage of Labor

The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.

The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014.

Study Overview

Detailed Description

The study was designed to be randomly controlled. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. 198 pregnant women were randomly assigned to the date fruit, nipple and control groups. From the 37th gestational age to the onset of labor, 6 date fruits were consumed per day by the date fruit group and the nipple stimulation was applied 6 minutes per day for the nipple group. No intervention was made for the control group. For the collection of research data, "Structured Information Form" and "Wijma Birth Expectancy / Experience Scale Version" were used.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women who nulliparous at the 37th gestational age, have singleton pregnancy, have the BMI is less than 25 kg/m2, planning to have a normal vaginal delivery, have vertex presentation, a volunteer to participate in the study, no smoking in pregnancy and have moderate birth fear according to W-DEQ were included in the study.

Exclusion Criteria:

  • Women who have risk pregnancy (such as preterm labor risk, preeclampsia eclampsia, premature rupture of membranes, placenta previa, gestational diabetes, fetal anomaly and chronic diseases) were excluded in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Date fruit group
  • Pregnant women were asked to consume 6 (about 65 gr) per day of dry date (Medjoul species) provided by the researcher until the birth of the 37th gestational age.
  • Dry date fruit provided by the researcher was given to the women to consume (42 pieces per week).
  • It has been stated that pregnancies should end the consumption of dates when actual uterine contractions begin.
  • Within the first 24 hours of labor, information on labor was recorded in the delivery file and "structured information form".
Consumption of Date Fruit
Experimental: Nipple group
  • The pregnancies are requested to stimulate a nipple (three minutes a day, one minute in the morning, one noon, one minute in the evening) and three minutes in the other nipple (one minute morning, one noon, one minute evening) with naked fingures and moderate pressure by pulling and rounding.
  • The pregnancies were stated to terminate the nipple stimulation when the actual uterine contractions onset.
  • Within the first 24 hours of labor, information on labor was recorded in the labor file and "structured information form".
Nipple Stimulation
No Intervention: Control group
• Within the first 24 hours of labor, information on labor was recorded in the delivery file and "structured information form".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The spontaneous onset of labor
Time Frame: From the 37th gestational age to the labor
The spontaneous onset of labor (dichotomous data: yes or no)
From the 37th gestational age to the labor
Induction and augmentation of labor
Time Frame: From the 37th gestational age to the labor
Induction and augmentation of labor (dichotomous data: yes or no)
From the 37th gestational age to the labor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: From the 37th gestational age to the birth
Mode of delivery (dichotomous data: vaginal delivery or caesarean section)
From the 37th gestational age to the birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gülay Rathfisch, Prof, Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2013

Primary Completion (Actual)

June 30, 2014

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 098

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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