Placental PreviaEarly Phase 1NCT06786156
Pregnant Women with Placenta Previa
A Early Phase 1 study testing Pecha Kucha Education in people with Placental Previa, run by Burdur Mehmet Akif Ersoy University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placental Previa
- What is being tested?
- Pecha Kucha Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Jul 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-45
- In the second trimester,
- Primiparous,
- With adequate communication skills
- Literate,
- Able to read and understand Turkish,
Who cannot join
- Having any mental illness
- Having communication, hearing or vision problems that prevent you from answering the data collection tools
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Placental Previa
- Being tested
- Pecha Kucha Education
- Keywords
- Fetal Movement, Pecha Kucha, Pregnancy Distress, Placental Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecha Kucha EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| INTERVENTION 1 | Experimental | Pecha Kucha Education Receives: Behavioral: Pecha Kucha Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal attachment scale
Measured: aseline and 3 months.
Tilburg pregnancy distress scale
Measured: aseline and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental PreviaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786156
- Sponsor's protocol ID
- 08.01.2025/01/26decision no
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fetal Movement Counting Given with Pecha Kucha Education on Prenatal Bonding and Pregnancy Distress in Pregnant Women with Placenta Previa
- ClinicalTrials.gov ID
- NCT06786156
- Acronym / sponsor ID
- 08.01.2025/01/26decision no
- Conditions
- Placental Previa
- Keywords
- Fetal Movement, Pecha Kucha, Pregnancy Distress, Placental Previa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| INTERVENTION 1 | Experimental | Behavioral: Pecha Kucha EducationPecha Kucha Education |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the ages of 18-45
Key exclusion criteria (2 listed)
- Having any mental illness
- Having communication, hearing or vision problems that prevent you from answering the data collection tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pecha Kucha EducationAfter 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 | Behavioural | INTERVENTION 1 |
Primary outcome
Prenatal attachment scale
Time frame: aseline and 3 months.
Tilburg pregnancy distress scale
Time frame: aseline and 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pecha Kucha Education in people with Placental Previa, run by Burdur Mehmet Akif Ersoy University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MİNE GÖKDUMAN (248 213 82 50, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal attachment scale (time frame: aseline and 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.