NCT06691854

Brief Summary

The effect of the ıntrapartum care model given in line with the world health organization (WHO) recommendations on women's perception of respectful maternity care, birth experiences and perception of traumatic birth

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

November 13, 2024

Last Update Submit

September 26, 2025

Conditions

Keywords

Respectful maternity care scaleBirth experience scaleTraumatic birth perception scaleWHO Intrapartum Care Recommendations

Outcome Measures

Primary Outcomes (6)

  • Comparison of sociodemographic characteristics of pregnant women before the intervention with the questionnaire

    Sociodemographic of pregnant women will be collected through surveys and compared and reported

    6 months

  • Comparison of pre-intervention obstetric characteristics of pregnant women with a questionnaire

    Obstetric of pregnant women will be collected through surveys and compared and reported

    6 months

  • Comparison of the delivery times of pregnant women through a survey

    The duration of labor of the groups will be collected through surveys and compared and reported

    6 months

  • Comparison of the means of the respectful birth care scale among pregnant women by group

    The respectful maternity care scale will be applied to pregnant women. The respectful maternity care scale is 19-95 points (min-max), and as the score increases, women's respectful maternity care increases.

    6 months

  • Comparison of the means of the birth experience scale among pregnant women by group

    The birth experience scale will be applied to pregnant women. The birth experience scale is 22-88 points (min-max), and as the score increases, it indicates that the expectant mother has a good birth experience.

    6 months

  • Comparison of the means of the traumatic birth perception scale among pregnant women by group

    The traumatic birth perception scale will be applied to pregnant women. The traumatic birth perception scale is 0-130 points (min-max). The scale shows that the 0-26 point range is "very low", the 27-52 point range is "low", the 53-78 point range is "medium", the 79-104 point range is "high", and the 105-130 point range is "very high" traumatic birth perception level.

    6 months

Study Arms (2)

Placebo group

NO INTERVENTION

Pregnant women who apply to the hospital for delivery, have a cervical dilatation of 5 cm or more, agree to participate in the study and are assigned to the control group; * A personal information form will be applied at the first clinic admission. * Pregnant women assigned to the control group will receive routine intrapartum care provided at the hospital. * The labor process of the pregnant woman will be recorded on the birth experience monitoring form. * The mother and baby will receive routine postpartum care provided at the hospital. * After delivery, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied.

The group that applied the Intrapartum Care Model

EXPERIMENTAL

Pregnant women who apply to the hospital for delivery, have cervical dilatation of 5 cm and above, agree to participate in the study and are assigned to the intervention group; * A Personal Information form will be applied at the first clinic admission. * All primiparous pregnant women assigned to the intervention group will be applied the intrapartum care model by the research midwife during the labor process and after birth in line with the WHO positive birth recommendations (Table 1). * The labor process of the pregnant woman will be recorded on the birth experience follow-up form. * After birth, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied.

Other: The group that applied the Intrapartum Care Model

Interventions

Pregnant women who apply to the hospital for delivery, have cervical dilatation of 5 cm and above, agree to participate in the study and are assigned to the intervention group; A Personal Information form will be applied at the first clinic admission. All primiparous pregnant women assigned to the intervention group will be applied the intrapartum care model by the research midwife during the labor process and after birth in line with the WHO positive birth recommendations. The labor process of the pregnant woman will be recorded on the birth experience follow-up form. After birth, the Respectful maternity care scale, Birth experience scale, Traumatic birth perception scale will be applied.

The group that applied the Intrapartum Care Model

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those who are 18 years of age or older,
  • Those who are in term pregnancy (38-41 weeks),
  • Those who are primiparous,
  • Those who have a single, healthy, vertex positioned fetus,
  • Those who have cervical dilatation of 5 cm or more,
  • Those who can speak and understand Turkish,
  • Those who voluntarily agree to participate in the research.

You may not qualify if:

  • Those with chronic diseases (hypertension, diabetes, etc.),
  • Those with a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.),
  • 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, cord prolapse, etc.),
  • Those with any complications that prevent vaginal birth (cephalopelvic disproportion, etc.),
  • Elective cesarean section,
  • Those who became pregnant with assisted reproductive techniques,
  • Those who received childbirth preparation training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seyhan Çankaya

Konya, Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Birth Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Seyhan Çankaya, PhD

    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
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 15, 2024

Study Start

December 1, 2024

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations