- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06786156
Pregnant Women with Placenta Previa
January 23, 2025 updated by: Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
The Effect of Fetal Movement Counting Given with Pecha Kucha Education on Prenatal Bonding and Pregnancy Distress in Pregnant Women with Placenta Previa
Placenta previa is the extension of placental tissue over the endocervical os or covering the cervical os.
Placenta previa is a common complication in the third trimester of pregnancy and is a major cause of postpartum hemorrhage and perinatal death.There are many studies in the literature on attachment.
However, no studies have been found on fetal movement in placenta previa pregnant women.
Counting fetal movements is an easy and inexpensive assessment that pregnant women can do on their own, without the need for any specialist or equipment, and for which they take responsibility.
It is assumed that the effective time spent during fetal movement counting will positively affect the attachment between the pregnant woman and the fetus, and that the stress of the pregnant woman, who is sure that her baby is well, will decrease.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MİNE GÖKDUMAN
- Phone Number: 248 213 82 50
- Email: minegokdumankeles@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Between the ages of 18-45
- In the second trimester,
- Primiparous,
- With adequate communication skills
- Literate,
- Able to read and understand Turkish,
Exclusion Criteria:
Having any mental illness
- Having communication, hearing or vision problems that prevent you from answering the data collection tools
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: INTERVENTION 1
Pecha Kucha Education
|
After the first interviews, the participants will be given face-to-face training to count fetal movements in the first stage.
The training will last 30-45 minutes.
The training content includes a comfortable environment and a suitable position for pregnant women, how to count and what to look for before counting fetal movements.
Then, the training will be sent to the pregnant women via WhatsApp.
A form will be given to count the fetal movements, and training will be applied using the Pecha Kucha method using smartphones once a week for 4 weeks.
Pecha kucha is a presentation method developed to attract and maintain the attention of the audience throughout a series of different presentations.
Pecha kucha (P-K), derived from the word meaning "chat" in Japanese, is to help present creative works with visual images.
Pecha kucha training includes position, how to count and what to look for before counting fetal movements.
This training will be delivered via WhatsApp with a practical presenta
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prenatal attachment scale
Time Frame: aseline and 3 months.
|
aseline and 3 months.
|
|
Tilburg pregnancy distress scale
Time Frame: aseline and 3 months.
|
aseline and 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2025
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
July 30, 2025
Study Registration Dates
First Submitted
January 15, 2025
First Submitted That Met QC Criteria
January 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 23, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08.01.2025/01/26decision 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
product manufactured in and exported from the U.S.
No
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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