- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06691854
Women's Perception of Respectful Maternity Care, Birth Experiences and Perception of Traumatic Birth
The Effect of the Intrapartum 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Konya
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Konya, Konya, Turkey (Türkiye), 42250
- Seyhan Çankaya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Placebo group
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;
|
|
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Experimental: The group that applied the Intrapartum Care Model
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;
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of sociodemographic characteristics of pregnant women before the intervention with the questionnaire
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seyhan Çankaya, PhD, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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