Comparison of Maternal and Neonatal Outcomes of Early and Late Admission to the Delivery Room
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kocaeli University
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- Neonatal pain and stress
Study Overview
Brief Summary
This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses.
Detailed Description
Aim: This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the latent and active phase.
Research hypothesis:
H1.1: There is a statistical difference between the two groups in terms of maternal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H1.2: There is a statistical difference between the two groups in terms of neonatal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
H0.1: There is no statistical difference between the two groups in terms of maternal outcomes of pregnant women who applied to the delivery room in the latent phase and pregnant women who applied in the active phase.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Ages 18 and over,
- •At term gestational age (37-42 weeks),
- •Does not have a risky pregnancy,
- •Single pregnancy,
- •Head presentation,
- •Literate participants will be included
Exclusion Criteria
- •Those who do not have sufficient mental health to fill out the survey form,
- •Visual, hearing, perception impaired
- •The newborn is unhealthy or stillborn,
- •With membrane rupture
- •Having a history of cesarean section
- •Those who have contraindications for vaginal birth
- •Having complaints of pregnancy-related bleeding,
- •Any risk of birth (placental abruption, uterine rupture, etc.)
- •Willing to leave at any point during the research
Outcomes
Primary Outcomes
Neonatal pain and stress
Time Frame: 15th minute after birth
ALPS-Neo: It is a 3-point Likert type scale consisting of 5 items: facial expression of the newborn, breathing pattern, tone of extremities, hand and foot activities and activity level. Measurements are made through observation. As stress and pain increase, the score obtained also increases. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and above 5 points indicate the presence of serious pain and stress.
Birth satisfaction
Time Frame: 5th hour postpartum
Birth satisfaction will be measured with a 10cm line visual analogue scale. The participant will be asked about her satisfaction with the birth and will be asked to mark his or her satisfaction on a visual analogue scale. The lowest score from the scale is 0, the highest score is 10.
Secondary Outcomes
- Maternal Anxiety(During the first 10 minutes of the participant's admission to the delivery room)
- Fear of Birth(During the first 10 minutes of the participant's admission to the delivery room)
Investigators
Sena Dilek Aksoy
Assistant Professor
Kocaeli University