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CompletedNCT06547177Updated Aug 19, 2024

The Effect of Nutrition and Fluid Intake in the First Stage of Labor

An interventional study of fruit juice in Labor Pain, Nutrient Intake and Fluid Therapy, sponsored by Hilal Yuvacı. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Hilal Yuvacı · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2022, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Labor Pain
  • Nutrient Intake
  • Fluid Therapy

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Keywords

  • Labor
  • nutrition
  • fluid
  • labor pain
  • maternal outcome
  • fetal outcome
03

In context

Labor Pain

410 studies on the registry are indexed under Labor Pain; 69 are open to participants now.

This study's enrollment of 90 is close to the median of 100 across 336 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Hilal Yuvacı is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • 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).

  • 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)

    Other: fruit juice

  • 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).

    Other: fruit juice

Interventions

  • Otherfruit juice

    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.

    Also known as: water

06

What researchers measure

Primary outcomes

  1. Maternal outcome

    During the research, duration of the latent and active phase of labor will be recorded.

    Time frame: The duration of the labor will measured from the latent phase of labor to birth.

  2. 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.

    Time frame: The study will be conducted from the latent phase of labor to birth.

  3. 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.

    Time frame: APGAR scores will be recorded after birth.

07

Study locations

1 site
  • Sakarya University School of Medicine
    Sakarya, Turkey (Türkiye)
08

References and documents

Study documents

  • Study protocol · Mar 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06547177
Lead sponsor
Hilal Yuvacı
Responsible party
Hilal Yuvacı (Assoc. Prof. Dr., Sakarya University) — Sponsor-investigator
First posted
Aug 9, 2024
Start date
Mar 22, 2022
Primary completion
Apr 15, 2023
Completion
Jan 20, 2024
Last update
Aug 19, 2024

Study contacts

Hilal Uslu Yuvacı
principal investigator · Sakarya University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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