Clinical trial NCT06681675: The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on the Birth Process and Care
Official title: The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on Labor Pain, Fear, Comfort, Duration, Oxytocin Use and Midwifery Care Perception: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Outcomes
Labor Pain and to Reduce Pain
Fear of Birth
Birth Comfort
Perception of Midwifery Care
Birth Period
Oxytocin Deficiency
WHO Intrapartum Care Recommendations
Keywords: WHO intrapartum care recommendations
Labor pain and to reduce pain
fear of birth
birth comfort
perception of midwifery care
Birth period
Oxytocin Deficiency
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effects of the intrapartum care model provided in line with the World Health Organization (WHO) recommendations on labor pain, fear, comfort, duration, oxytocin use and perception of midwifery care.

Detailed description: The research is a randomized controlled trial. The research was conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of Aksaray Training and Research Hospital between September 2023 and January 2024. The pregnant women in the intervention group were given the intrapartum care model in line with WHO recommendations after cervical dilation reached 5 cm. The control group received only the standard intrapartum care in the hospital. Data were collected using the personal information form, labor and postpartum follow-up form, Visual Analog Scale (VAS), Labor Comfort Scale (DKS), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Childbirth Scale. VAS, DKS, and Fear of Childbirth scale were applied to women in both groups when cervical dilation was 5 cm and 9 cm. After birth, the Women's Perception of Supportive Care Given During Childbirth scale was applied.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older,
* History of term pregnancy (38-42 weeks),
* Having a primiparous,
* Single, healthy, vertex positioned fetus,
* Having no complications that may cause dystocia in labor (such as contraction anomalies, birth object,
* Birth canal dystocia, dystocia related to the mother's psychology),
* Having a partner/husband,
* History of cervical dilatation of 5 cm or more,
* Being able to speak and understand Turkish

Exclusion Criteria:

* Those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, etc.),
* Those with any complications that prevent vaginal delivery,
* Elective caesarean section, those who became pregnant with assisted reproductive techniques,
* Those who are multiparous,
* Those who have chronic diseases (such as hypertension, diabetes, heart disease).

Primary outcomes:
measure: Comparison of pre-intervention sociodemographic of pregnant women
timeFrame: 6 months
measure: Comparison of pre-intervention obstetric features of pregnant women
timeFrame: 6 months
measure: Comparison of labor characteristics of pregnant women before intervention
timeFrame: 6 months
measure: Comparison of postpartum characteristics of pregnant women
timeFrame: 6 months
measure: Comparison of duration of labor of groups
timeFrame: 6 months
measure: Comparison of pregnant women's VAS (pain perception) mean scores by groups
timeFrame: 6 months
measure: Comparison of pregnant women's fear of childbirth average scores by groups
timeFrame: 6 months
measure: Comparison of pregnant women's birth comfort score averages by groups
timeFrame: 6 months
measure: Comparison of mean scores of the scale of women's perception of supportive care given during childbirth by groups
timeFrame: 6 months
measure: Comparison of oxytocin use by groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Seyhan Çankaya, Assoc.Prof
role: PRINCIPAL_INVESTIGATOR
References: