The Effect of Nutrition and Fluid Intake in the First Stage of Labor
1 other identifier
interventional
90
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2022
CompletedFirst Submitted
Initial submission to the registry
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedAugust 19, 2024
August 1, 2024
1.1 years
December 20, 2022
August 15, 2024
Conditions
Keywords
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 INTERVENTIONPregnant 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
EXPERIMENTALFruit 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
EXPERIMENTALWater (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).
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.
Eligibility Criteria
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
- Hilal Yuvacılead
Study Sites (1)
Sakarya University School of Medicine
Sakarya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hilal Uslu Yuvacı
Sakarya University School of Medicine
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