- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06547177
The Effect of Nutrition and Fluid Intake in the First Stage of Labor
The Effect of Nutrition and Fluid Intake in the First Stage of Labor on Maternal and Fetal Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Method of Study: The study was planned as a randomized controlled experimental study to evaluate the effect of fluid intake during labor on mothers and babies.
Location and Characteristics of the Research: The research will be conducted in the delivery room of Sakarya Training and Research Hospital.
Population and Sample of the Study: The research will consist of pregnant women who apply to Sakarya Training and Research Hospital with signs of the onset of labor and will have an expected vaginal delivery in the delivery room. Annually, 7000-8000 women give birth in the hospital, and approximately 50% have an expected vaginal delivery. All pregnant women who met the sampling criteria and volunteered to participate in the study during the study's implementation will be included. The research will be carried out in 3 groups experimental and control groups. The study will be conducted with a total of 90 pregnant women, 30 of whom are in each group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sakarya, Turkey
- Sakarya University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer to participate in the research
- Agreeing to abide by the protocol
- Being able to read and write,
- Ages 18-35 years
- 37-40 Pregnancy weeks
- First pregnancy,
- Single fetus
- BMI ≤ 28,
- Head presentation
- Cervical dilatation of <6 cm or less (latent phase)
- Height ≥ 1.50 cm
Exclusion Criteria:
- Communication barriers (speech, hearing, mental),
- Disability (physical or mental problem, drug use),
- Chronic diseases (hypertension, diabetes, etc),
- Gastrointestinal problems before and during pregnancy
- Comply with the fluid intake protocol during labor,
- Pregnant women who are scheduled for elective cesarean section
- Pregnant women considered to be at immediate cesarean risks, such as diabetic pregnant women with cephalopelvic incompatibility, multiple pregnancies, preeclampsia, and macrosomic fetus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: control
Pregnant women in the study's control group will not be subjected to any application other than routine hospital practices.
They will not consume oral liquid or solid food, and their fluid needs will be met with 125 ml/hour of intravenous(iv) fluid (5% dextrose).
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Experimental: Water group
Water (as much as desired in 100 ml containers during the latent phase) (total water amount will be recorded).
Pregnant women in all groups will not take oral fluids after transitioning to the active phase (> 6 cm cervical dilatation).
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During labor, one group will follow the routine while the water group will only take water and fruit juice group will take water and fruit juice.
Other Names:
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Experimental: Fruit juice and water group
Fruit juice (100 ml juice once in the first hour of admission to the delivery room during the latent phase) = (cherry/apple juice, 100 ml, 50-54 kcal), then every 4 hours.
It will be given in 100 ml.
In addition, they will be allowed to take small amounts of water.
(Total fluid intake will be recorded)
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During labor, one group will follow the routine while the water group will only take water and fruit juice group will take water and fruit juice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maternal outcome
Time Frame: The duration of the labor will measured from the latent phase of labor to birth.
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During the research, duration of the latent and active phase of labor will be recorded.
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The duration of the labor will measured from the latent phase of labor to birth.
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Maternal pain outcome
Time Frame: The study will be conducted from the latent phase of labor to birth.
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A visual analogue scale (VAS) was used to measure the levels of labor pain.
VAS scores will be recorded from the latent phase of labor to birth.The VAS was a 0 to 100 mm line (from no pain to worst imaginable pain).
Over 60 mm on the VAS indicates severe pain, moderate pain ranges from 40 - 60 mm and mild pain is under 40 mm.
The higher scores implied the higher level of pain.
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The study will be conducted from the latent phase of labor to birth.
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fetal outcomes
Time Frame: APGAR scores will be recorded after birth.
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The Apgar score is a standardized assessment of a neonate's status immediately after birth and the response to resuscitation efforts and remains the gold standard for evaluating neonates.
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APGAR scores will be recorded after birth.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilal Uslu Yuvacı, Sakarya University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fluid intake in labor
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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