NCT06547177

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration 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

March 22, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

December 20, 2022

Last Update Submit

August 15, 2024

Conditions

Keywords

Labornutritionfluidlabor painmaternal outcomefetal outcome

Outcome Measures

Primary Outcomes (3)

  • Maternal outcome

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

    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.

    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.

    APGAR scores will be recorded after birth.

Study Arms (3)

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)

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).

Other: fruit juice

Interventions

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
Fruit juice and water groupWater group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer to participate in the research
  • Agreeing to abide by the protocol
  • Being able to read and write,
  • Ages 18-35 years
  • Pregnancy weeks
  • First pregnancy,
  • Single fetus
  • BMI ≤ 28,
  • Head presentation
  • Cervical dilatation of \<6 cm or less (latent phase)
  • Height ≥ 1.50 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University School of Medicine

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Fruit and Vegetable JuicesWater

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Hilal Uslu Yuvacı

    Sakarya University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

December 20, 2022

First Posted

August 9, 2024

Study Start

March 22, 2022

Primary Completion

April 15, 2023

Study Completion

January 20, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations