Clinical trial NCT06547177: The Effect of Nutrition and Fluid Intake in the First Stage of Labor
Official title: The Effect of Nutrition and Fluid Intake in the First Stage of Labor on Maternal and Fetal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Nutrient Intake
Fluid Therapy
Keywords: Labor
nutrition
fluid
labor pain
maternal outcome
fetal outcome
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal outcome
timeFrame: The duration of the labor will measured from the latent phase of labor to birth.
measure: Maternal pain outcome
timeFrame: The study will be conducted from the latent phase of labor to birth.
measure: fetal outcomes
timeFrame: APGAR scores will be recorded after birth.
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University School of Medicine
Study officials:
affiliation: Sakarya University School of Medicine
name: Hilal Uslu Yuvacı
role: PRINCIPAL_INVESTIGATOR
References: