Placenta, RetainedNCT06677294
The Effects of Intrauterine Interventions During Placenta Removal on Pain, Perception of Traumatic Birth, and Early Postpartum Health Indicators in Women
An observational study of Placenta, Retained, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
A prospective cohort study was conducted with 64 women who had vaginal deliveries at Adana City Training and Research Hospital between October 2023 and May 2024. Women who received intrauterine interventions during the third stage of labor formed the case group (n=32), and those who did not formed the control group… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta, Retained
- What is being tested?
- Placenta remove
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 15 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The inclusion criteria required participants to be 18 years or older, to have delivered at term (38-40 weeks), to have had a vaginal delivery, and to have a singleton pregnancy.
Who may be able to join
- The inclusion criteria required participants to be 18 years or older, to have delivered at term (38-40 weeks), to have had a vaginal delivery, and to have a singleton pregnancy. Additionally, participants must not have been using analgesic medications, must not have had hypertension or preeclampsia, and must not have experienced atony in a previous pregnancy. Participants also needed to be free from infections, placental anomalies, genital lesions, or coagulation disorders, and they had to agree to participate in the study
Who cannot join
- Exclusion criteria included women who experienced a difficult labor or whose delivery involved the use of forceps or vacuum assistance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş
About this study
A prospective cohort study was conducted with 64 women who had vaginal deliveries at Adana City Training and Research Hospital between October 2023 and May 2024. Women who received intrauterine interventions during the third stage of labor formed the case group (n=32), and those who did not formed the control group (n=32). Data were collected using the Pregnant Information Form, Labor Observation Form, Early Postpartum Period Follow-up Form, Visual Analog Scale (VAS), and Traumatic Birth Perception Scale (TBPS). Findings were determined through regular monitoring and follow-ups during the first 24 hours postpartum.
- Conditions
- Placenta, Retained
- Being tested
- Placenta remove
- Medical subject headings
- Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placenta removeProcedure or surgery
This is an observational study. No intervention was performed
| Study group | Role | What they receive |
|---|---|---|
| Control | while those who did not undergo such interventions were placed in the control group Receives: Procedure: Placenta remove | |
| Case | In the study, women who underwent intrauterine interventions during the third stage of labor for placental removal were included in the case group (n=32), while those who did not undergo such interventions were placed in the control group (n=32). Manual placental removal (hallas) and the cleaning of the uterine cavity using the hand or gauze/sponge (wrapped around the hand or using an over-clamp) after placental expulsion were considered intrauterine interventions Receives: Procedure: Placenta remove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's pain levels
The Visual Analog Scale (VAS) was used to assess pain levels in this study. The VAS is a continuous scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores on the VAS indicate a worse outcome, as they reflect greater levels of reported pain.
Measured: VAS scores were recorded at 10 minutes, 30 minutes, 1 hour, 12 hours, and 24 hours postpartum
Traumatic Birth Perception
The Traumatic Birth Perception Scale (TBPS) was developed to measure the perception of traumatic birth in women and consists of 13 items within a single subdimension. There are no reverse-scored items in the scale, and each item is rated on a scale of 0 to 10. The lowest possible score is 0, and the highest possible score is 130. The total score reflects the level of traumatic birth perception, with higher scores indicating a higher perception of trauma related to the birth experience.
Measured: At 24 hours postpartum
Early postpartum health characteristics
Measured: 10th minute, 15th minute, 20th minute, 30th minute, 45th minute, 60th minute, 90th minute, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 12th hour, 18th hour and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start15 Sep 2023
- Primary completion15 Jan 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta, RetainedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Akyıldız, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677294
- Sponsor's protocol ID
- Placenta Removal Interventions
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intrauterine Interventions During Placenta Removal on Pain, Perception of Traumatic Birth, and Early Postpartum Health Indicators in Women
- ClinicalTrials.gov ID
- NCT06677294
- Acronym / sponsor ID
- Placenta Removal Interventions
- Conditions
- Placenta, Retained
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 6 Nov 2024 (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.
A prospective cohort study was conducted with 64 women who had vaginal deliveries at Adana City Training and Research Hospital between October 2023 and May 2024. Women who received intrauterine interventions during the third stage of labor formed the case group (n=32), and those who did not formed the control group (n=32). Data were collected using the Pregnant Information Form, Labor Observation Form, Early Postpartum Period Follow-up Form, Visual Analog Scale (VAS), and Traumatic Birth Perception Scale (TBPS). Findings were determined through regular monitoring and follow-ups during the first 24 hours postpartum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: Placenta removewhile those who did not undergo such interventions were placed in the control group |
| Case | – | Procedure: Placenta removeIn the study, women who underwent intrauterine interventions during the third stage of labor for placental removal were included in the case group (n=32), while those who did not undergo such interventions were placed in the control group (n=32). Manual placental removal (hallas) and the cleaning of the uterine cavity using the hand or gauze/sponge (wrapped around the hand or using an over-clamp) after placental expulsion were considered intrauterine interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria required participants to be 18 years or older, to have delivered at term (38-40 weeks), to have had a vaginal delivery, and to have a singleton pregnancy.
Key inclusion criteria (1 listed)
- The inclusion criteria required participants to be 18 years or older, to have delivered at term (38-40 weeks), to have had a vaginal delivery, and to have a singleton pregnancy. Additionally, participants must not have been using analgesic medications, must not have had hypertension or preeclampsia, and must not have experienced atony in a previous pregnancy. Participants also needed to be free from infections, placental anomalies, genital lesions, or coagulation disorders, and they had to agree to participate in the study
Key exclusion criteria (1 listed)
- Exclusion criteria included women who experienced a difficult labor or whose delivery involved the use of forceps or vacuum assistance.
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 |
|---|---|---|
| Placenta removeThis is an observational study. No intervention was performed | Procedure or surgery | Case, Control |
Primary outcome
Women's pain levels
Time frame: VAS scores were recorded at 10 minutes, 30 minutes, 1 hour, 12 hours, and 24 hours postpartum
The Visual Analog Scale (VAS) was used to assess pain levels in this study. The VAS is a continuous scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Higher scores on the VAS indicate a worse outcome, as they reflect greater levels of reported pain.
Traumatic Birth Perception
Time frame: At 24 hours postpartum
The Traumatic Birth Perception Scale (TBPS) was developed to measure the perception of traumatic birth in women and consists of 13 items within a single subdimension. There are no reverse-scored items in the scale, and each item is rated on a scale of 0 to 10. The lowest possible score is 0, and the highest possible score is 130. The total score reflects the level of traumatic birth perception, with higher scores indicating a higher perception of trauma related to the birth experience.
Early postpartum health characteristics
Time frame: 10th minute, 15th minute, 20th minute, 30th minute, 45th minute, 60th minute, 90th minute, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 12th hour, 18th hour and 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta, Retained, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's pain levels (time frame: VAS scores were recorded at 10 minutes, 30 minutes, 1 hour, 12 hours, and 24 hours postpartum). The study lists 3 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 6 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.