- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280911
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
Status
Completed
Conditions
Intervention / Treatment
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
|
Consumption of Date Fruit
|
|
Experimental: Nipple group
|
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.
Sponsor
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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