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NCT Number: NCT06547177

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

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.

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Key information

Conditions

Labor Pain Fluid Therapy Neurologic Manifestations Nutrient Intake Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University School of Medicine

Sakarya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fruit juice

Other

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: water

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hilal Yuvacı

Other

Registry information

Official study title

The Effect of Nutrition and Fluid Intake in the First Stage of Labor on Maternal and Fetal Outcomes

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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