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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06280911
Other study ID # 098
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2013
Est. completion date December 30, 2017

Study information

Verified date February 2024
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date December 30, 2017
Est. primary completion date June 30, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Date Fruit group
Consumption of Date Fruit
Nipple group
Nipple Stimulation

Locations

Country Name City State
Turkey Zeynep Kamil Women's and Children's Diseases Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The spontaneous onset of labor The spontaneous onset of labor (dichotomous data: yes or no) From the 37th gestational age to the labor
Primary Induction and augmentation of labor Induction and augmentation of labor (dichotomous data: yes or no) From the 37th gestational age to the labor
Secondary Mode of delivery Mode of delivery (dichotomous data: vaginal delivery or caesarean section) From the 37th gestational age to the birth
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