Labor PainNCT06547177
The Effect of Nutrition and Fluid Intake in the First Stage of Labor
A study testing fruit juice in people with Labor Pain and Nutrient Intake, run by Hilal Yuvacı at 1 site in Turkey (Türkiye).
Trial summary
Birth is a process that requires large amounts of energy. As a result of skeletal and smooth muscle contractions at birth, the body's basal metabolic rate, energy requirement, hydration requirement, and insensible fluid loss are significantly increased. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Nutrient Intake, Fluid Therapy
- What is being tested?
- fruit juice
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2022to 20 Jan 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 11Show fewer
- Single fetus
- BMI ≤ 28,
- Head presentation
- Cervical dilatation of <6 cm or less (latent phase)
- Height ≥ 1.50 cm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nutrition and Fluid Intake in the First Stage of Labor on Maternal and Fetal Outcomes
Birth is a process that requires large amounts of energy. As a result of skeletal and smooth muscle contractions at birth, the body's basal metabolic rate, energy requirement, hydration requirement, and insensible fluid loss are significantly increased. Information regarding the safety and effectiveness of increased hydration during labor is still controversial. There is no consensus on whether this hydration should be given with intravenous solutions or orally. The study aims to determine the effect of fluid intake in labor on the delivery process, maternal-fetal outcomes, and postpartum satisfaction of the mother.
Read the 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.
- Conditions
- Labor Pain, Nutrient Intake, Fluid Therapy
- Being tested
- fruit juice
- Keywords
- Labor, nutrition, fluid, labor pain, maternal outcome, fetal outcome
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruit juiceOther
Also called water
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.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | 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). |
| Fruit juice and water group | Experimental | 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) Receives: Other: fruit juice |
| Water group | Experimental | 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). Receives: Other: fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcome
During the research, duration of the latent and active phase of labor will be recorded.
Measured: The duration of the labor will measured from the latent phase of labor to birth.
Maternal pain outcome
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.
Measured: The study will be conducted from the latent phase of labor to birth.
fetal outcomes
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.
Measured: APGAR scores will be recorded after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start22 Mar 2022
- Primary completion15 Apr 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Yuvacı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yuvacı, Sakarya University
- Investigators
- Hilal Uslu Yuvacı, Principal investigator, Sakarya University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547177
- Sponsor's protocol ID
- fluid intake in labor
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrition and Fluid Intake in the First Stage of Labor on Maternal and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT06547177
- Acronym / sponsor ID
- fluid intake in labor
- Conditions
- Labor Pain, Nutrient Intake, Fluid Therapy
- Keywords
- Labor, nutrition, fluid, labor pain, maternal outcome, fetal outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hilal YuvacıUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 9 Aug 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.
Birth is a process that requires large amounts of energy. As a result of skeletal and smooth muscle contractions at birth, the body's basal metabolic rate, energy requirement, hydration requirement, and insensible fluid loss are significantly increased. Information regarding the safety and effectiveness of increased hydration during labor is still controversial. There is no consensus on whether this hydration should be given with intravenous solutions or orally. The study aims to determine the effect of fluid intake in labor on the delivery process, maternal-fetal outcomes, and postpartum satisfaction of the mother.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –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). |
| Fruit juice and water group | Experimental | Other: fruit juiceFruit 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) |
| Water group | Experimental | Other: fruit juiceWater (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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| fruit juiceAlso: waterDuring 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 | Fruit juice and water group, Water group |
Primary outcome
Maternal outcome
Time frame: The duration of the labor will measured from the latent phase of labor to birth.
During the research, duration of the latent and active phase of labor will be recorded.
Maternal pain outcome
Time frame: The study will be conducted from the latent phase of labor to birth.
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.
fetal outcomes
Time frame: APGAR scores will be recorded after birth.
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.
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 19 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Hilal Uslu Yuvacı principal investigator
Sakarya University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fruit juice in people with Labor Pain and Nutrient Intake, run by Hilal Yuvacı 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 11 inclusion and 7 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 19 Aug 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?
Maternal outcome (time frame: The duration of the labor will measured from the latent phase of labor to birth.). The study lists 3 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 19 Aug 2024.