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

NCT ID: NCT06681675

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-01-01

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

The group that applied the Intrapartum Care Model

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Seyhan Çankaya

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyhan Çankaya, Assoc.Prof

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

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Selcuk University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40314363 (View on PubMed)

Other Identifiers

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2023/671

Identifier Type: -

Identifier Source: org_study_id

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