NCT06280911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

February 19, 2024

Last Update Submit

February 29, 2024

Conditions

Keywords

AugmentationDate fruitInductionLaborNipple Stimulation

Outcome Measures

Primary Outcomes (2)

  • The spontaneous onset of labor

    The spontaneous onset of labor (dichotomous data: yes or no)

    From the 37th gestational age to the labor

  • Induction and augmentation of labor

    Induction and augmentation of labor (dichotomous data: yes or no)

    From the 37th gestational age to the labor

Secondary Outcomes (1)

  • Mode of delivery

    From the 37th gestational age to the birth

Study Arms (3)

Date fruit group

EXPERIMENTAL

* 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".

Other: Date Fruit group

Nipple group

EXPERIMENTAL

* 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".

Other: Nipple group

Control group

NO INTERVENTION

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

Interventions

Consumption of Date Fruit

Date fruit group

Nipple Stimulation

Nipple group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant Women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Self Stimulation

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gülay Rathfisch, Prof

    Atlas University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was designed to be randomly controlled.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

October 10, 2013

Primary Completion

June 30, 2014

Study Completion

December 30, 2017

Last Updated

March 4, 2024

Record last verified: 2024-02

Locations