AugmentationNCT06280911
The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy
A study testing Date Fruit group and Nipple group in people with Augmentation and Induction, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Augmentation, Induction, Labor
- What is being tested?
- Date Fruit group and Nipple group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2013to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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
- Being tested
- Date Fruit group, Nipple group
- Keywords
- Augmentation, Date fruit, Induction, Labor, Nipple Stimulation
- Medical subject headings
- Self Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date Fruit groupOther
Consumption of Date Fruit
Nipple groupOther
Nipple Stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: 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". Receives: 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
The spontaneous onset of labor
The spontaneous onset of labor (dichotomous data: yes or no)
Measured: From the 37th gestational age to the labor
Induction and augmentation of labor
Induction and augmentation of labor (dichotomous data: yes or no)
Measured: From the 37th gestational age to the labor
Secondary outcomes (1)
Mode of delivery
Mode of delivery (dichotomous data: vaginal delivery or caesarean section)
Measured: From the 37th gestational age to the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start10 Oct 2013
- Primary completion30 Jun 2014
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AugmentationStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed to be randomly controlled.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime Esra Meram, Selcuk University
- Investigators
- Gülay Rathfisch, Prof, Study director, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280911
- Sponsor's protocol ID
- 098
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy on The First Stage of Labor
- ClinicalTrials.gov ID
- NCT06280911
- Acronym / sponsor ID
- 098
- Conditions
- Augmentation, Induction, Labor, Stimulation, Self
- Keywords
- Augmentation, Date fruit, Induction, Labor, Nipple Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 10 Oct 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study was designed to be randomly controlled.
| Arm | Type | Receives |
|---|---|---|
| Date fruit group | Experimental | Other: 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". |
| Nipple group | Experimental | Other: 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". |
| Control group | No intervention | –• Within the first 24 hours of labor, information on labor was recorded in the delivery file and "structured information form". |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Date Fruit groupConsumption of Date Fruit | Other | Date fruit group |
| Nipple groupNipple Stimulation | Other | Nipple group |
Primary outcome
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)
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)
1 secondary outcome
Mode of delivery
Time frame: From the 37th gestational age to the birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay Rathfisch, Prof study director
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Date Fruit group and Nipple group in people with Augmentation and Induction, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The spontaneous onset of labor (time frame: From the 37th gestational age to the labor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.