The Effect of the Intrapartum Care Model Given in Line With WHO Recommendations on the Birth Process and Care

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

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.

Study Overview

• Status: Completed
• Conditions: Birth Outcomes; Oxytocin Deficiency; Labor Pain and to Reduce Pain; Fear of Birth; Birth Comfort; Perception of Midwifery Care; Birth Period; WHO Intrapartum Care Recommendations
• Intervention / Treatment: Procedure: The group that applied the Intrapartum Care Model

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42250
    • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo group; No intervention was made to the primiparous pregnant women in the control group other than routine intrapartum care applied in the hospital. After being admitted to the hospital for delivery, the pregnant women in the control group were informed about the study. Written consent was obtained. A personal information form was applied at the first clinic admission. When the cervical dilatation was 5 cm, VAS, Fear of Childbirth and Childbirth Comfort scales were applied. When the cervical dilatation was 9 cm, the labor monitoring form, VAS, Fear of Childbirth and Childbirth Comfort scales were applied. The routine practices and care of the maternity ward affiliated to the hospital were performed (anamnesis was taken, file was filled, intravenous access was established, routine blood tests were taken, vital signs were taken, enema was performed, vaginal examination every two hours and cervical changes were recorded on the partograph, continuous EFM (Electronic Fetal Monitoring) was applied
Experimental: The group that applied the Intrapartum Care Model; In pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission. •The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations. Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied.	Procedure: The group that applied the Intrapartum Care Model; In pregnant women with cervical dilatation of 5 cm, the Personal Information Form was completed at the initial clinic admission. •The Intrapartum Care Model was implemented for all primiparous pregnant women assigned to the intervention group during labor and after delivery by the researcher midwife, in accordance with the World Health Organization's positive birth recommendations. Data were collected using the Personal Information Form, Labor and Postpartum Follow-up Form, Visual Analog Scale (VAS), Labor Comfort Scale (CSC), Intrapartum Fear of Labor Scale, and Women's Perception of Supportive Care Given During Labor Scale. VAS, CSC, and Fear of Labor Scale were applied to women when cervical dilation was 5 cm and 9 cm. After delivery, the Women's Perception of Supportive Care Given During Labor Scale was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of postpartum characteristics of pregnant women	Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.	6 months
Comparison of pre-intervention obstetric features of pregnant women	Obstetric of pregnant women will be collected through surveys and compared and reported.	6 months
Comparison of pre-intervention sociodemographic of pregnant women	Sociodemographic of pregnant women will be collected through surveys and compared and reported	6 months
Comparison of labor characteristics of pregnant women before intervention	Labor Characteristics of pregnant women will be collected through questionnaires and compared and reported.	6 months
Comparison of duration of labor of groups	The duration of labor of the groups will be collected through surveys and compared and reported.	6 months
Comparison of pregnant women's VAS (pain perception) mean scores by groups	VAS (pain perception) scale will be applied to pregnant women. The pain scale (VAS) is 1-10 points (min-max), and as the score increases, women's pain perception also increases.	6 months
Comparison of pregnant women's fear of childbirth average scores by groups	A fear of childbirth scale will be applied to pregnant women. The fear of childbirth scale is 10-100 points (min-max), and as the score increases, women's fear of childbirth increases.	6 months
Comparison of pregnant women's birth comfort score averages by groups	A birth comfort scale will be applied to pregnant women. The birth comfort scale is 9-45 points (min-max), and as the score increases, women's birth comfort increases.	6 months
Comparison of mean scores of the scale of women's perception of supportive care given during childbirth by groups	A scale of women's perception of supportive care given during childbirth will be applied to pregnant women. The scale of women's perception of supportive care given during childbirth is 33-132 points (min-max), and as the score increases, women's perception of care increases.	6 months
Comparison of oxytocin use by groups	Oxytocin use by groups will be collected via survey and reported by comparison.	6 months

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Seyhan Çankaya, Assoc.Prof, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: birth comfort; fear of birth; WHO intrapartum care recommendations; Labor pain and to reduce pain; perception of midwifery care; Birth period; Oxytocin Deficiency
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 2023/671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No