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

NCT06681675 | Completed

• 1 other identifier: 2023/671
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• 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 pre-intervention obstetric features of pregnant women

  Obstetric 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 postpartum characteristics of pregnant women

  Postpartum characteristics of pregnant women will be collected through surveys 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

Study Arms (2)

Placebo group

NO INTERVENTION

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

The group that applied the Intrapartum Care Model

EXPERIMENTAL

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

Interventions

The group that applied the Intrapartum Care Model PROCEDURE

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.

The group that applied the Intrapartum Care Model

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (1)

• Mangir Meler K, Cankaya S. The effect of intrapartum care model given in line with World Health Organization (WHO) recommendations on labor pain, fear of labor, comfort of labor, duration of labor, administration of oxytocin and perception of midwifery care: a randomized controlled study. Postgrad Med. 2025 Jun;137(5):379-395. doi: 10.1080/00325481.2025.2501943. Epub 2025 May 11.

  PMID: 40314363 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Seyhan Çankaya, Assoc.Prof

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)