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

NCT ID: NCT06280911

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2017-12-30

Brief 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.

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.

Conditions

Augmentation; Induction; Labor; Stimulation, Self

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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".

Group Type: EXPERIMENTAL

Date Fruit group

Intervention Type: OTHER

Consumption of Date Fruit

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".

Group Type: EXPERIMENTAL

Nipple group

Intervention Type: OTHER

Nipple Stimulation

Control group

• Within the first 24 hours of labor, information on labor was recorded in the delivery file and "structured information form".

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Date Fruit group

Consumption of Date Fruit

Intervention Type: OTHER

Nipple group

Nipple Stimulation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Halime Esra Meram

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay Rathfisch, Prof

Role: STUDY_DIRECTOR

Atlas University

Locations

Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

098

Identifier Type: -

Identifier Source: org_study_id