Placenta Accreta SpectrumNCT06808165
Relaxin and Placental Volume in Placenta Accreta Spectrum
An observational study of Placenta Accreta Spectrum and Placenta Accreta / Percreta, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective case-control study investigated the potential role of circulating relaxin levels and estimated placental volumes (EPV) in the pathogenesis and diagnosis of placenta accreta spectrum (PAS) disorders. It compared these parameters in patients diagnosed with PAS versus healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta Spectrum, Placenta Accreta / Percreta
- What is being tested?
- relaxin
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of two groups. Following retrospective investigation of patients operated in our clinic between 01.01.2022 and 01.12.2022, the case group included 20 patients diagnosed with PAS disorders, suspected with clinical and imaging findings, confirmed through histopathological findings. These patients had undergone elective cesarean hysterectomy and met inclusion criteria aged between 18 and 45 years and availability of complete medical records. Due to ethical considerations, 4 patients diagnosed with PAS who underwent emergency surgery because of vaginal bleeding and 14 patients operated with segmentary resections were excluded from the study to compose more homogenous study cohort for the measurement of EPV. The control group consisted of 20 healthy pregnant women who underwent the first planned cesarean section of the day, without any obstetric complications, on the same days when planned PAS cesarean-hysterectomy cases were performed in 2022.
Who may be able to join
- Women aged 18-45 years
- Confirmed histopathological diagnosis of PAS (case group)
- Complete medical records
- Healthy pregnant women undergoing cesarean delivery (control group)
Who cannot join
- Multifetal gestation
- Emergency surgeries
- Incomplete medical records
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul, Turkey
About this study
Official title: Evaluation of Relaxin and Placental Volume in Placenta Accreta Spectrum Disorders: A Case-Control Study
This retrospective case-control study investigated the potential role of circulating relaxin levels and estimated placental volumes (EPV) in the pathogenesis and diagnosis of placenta accreta spectrum (PAS) disorders. It compared these parameters in patients diagnosed with PAS versus healthy controls.
Read the detailed description
This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta).A retrospective case-control study was conducted at a tertiary referral center, analyzing data from January 2022 to December 2022.
- Being tested
- relaxin
- Keywords
- Biomarker, PAS, Placenta Accreta Spectrum, Placental Volume, Relaxin, RLN2
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxinDiagnostic test
The primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altCirculating relaxin levels were assessed before routinely storing maternal venous blood and umbilical cord arterial blood samples are anelyzed. This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta).
| Study group | Role | What they receive |
|---|---|---|
| Placenta Accreta Spectrum Group | * 20 patients diagnosed with PAS, confirmed through histopathological findings post-cesarean hysterectomy
* Blood and placental tissue analyzed for relaxin levels and placental volume
* Subgroup analysis based on PAS severity (accreta, increta, percreta) Receives: Diagnostic Test: relaxin | |
| Control Group (No PAS Pathology with Elective Cesarean Section) | * 20 healthy pregnant women undergoing elective cesarean section
* Blood and placental volume assessed Receives: Diagnostic Test: relaxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating relaxin (RLN2) levels in peripheral and umbilical cord blood
The primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altered expression of relaxin, its receptor RXFP1, and insulin-like peptide 4 (INSL4) in PAS cases, suggesting potential roles in its pathogenesis.
Measured: 11 months
Secondary outcomes (1)
placental volume
Placental volume, assessed through imaging modalities, has been explored as a potential biomarker for abnormal placental development, including PAS. Studies have demonstrated that larger placental volumes may be associated with invasive placentation, suggesting a correlation between placental growth patterns and PAS severity.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jan 2022
- Primary completion1 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Placenta Accreta SpectrumStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808165
- Sponsor's protocol ID
- KAEK/2023.01.20
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burston HE, Kent OA, Communal L, Udaskin ML, Sun RX, Brown KR, Jung E, Francis KE, La Rose J, Lowitz J, Drapkin R, Mes-Masson AM, Rottapel R. Inhibition of relaxin autocrine signaling confers therapeutic vulnerability in ovarian cancer. J Clin Invest. 2021 Apr 1;131(7):e142677. doi: 10.1172/JCI142677.
PubMed 33561012Ma P, Hu T, Chen Y. The Association and diagnostic value between Maternal Serum Placental Markers and Placenta Previa. Eur J Obstet Gynecol Reprod Biol X. 2024 Oct 11;24:100346. doi: 10.1016/j.eurox.2024.100346. eCollection 2024 Dec.
PubMed 39483207Patil NA, Rosengren KJ, Separovic F, Wade JD, Bathgate RAD, Hossain MA. Relaxin family peptides: structure-activity relationship studies. Br J Pharmacol. 2017 May;174(10):950-961. doi: 10.1111/bph.13684. Epub 2017 Jan 19.
PubMed 27922185Goh W, Yamamoto SY, Thompson KS, Bryant-Greenwood GD. Relaxin, its receptor (RXFP1), and insulin-like peptide 4 expression through gestation and in placenta accreta. Reprod Sci. 2013 Aug;20(8):968-80. doi: 10.1177/1933719112472735. Epub 2013 Jan 9.
PubMed 23302396
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Relaxin and Placental Volume in Placenta Accreta Spectrum Disorders: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06808165
- Acronym / sponsor ID
- KAEK/2023.01.20
- Keywords
- Biomarker, PAS, Placenta Accreta Spectrum, Placental Volume, Relaxin, RLN2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 5 Feb 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.
This retrospective case-control study investigated the potential role of circulating relaxin levels and estimated placental volumes (EPV) in the pathogenesis and diagnosis of placenta accreta spectrum (PAS) disorders. It compared these parameters in patients diagnosed with PAS versus healthy controls.
Detailed description
This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta).A retrospective case-control study was conducted at a tertiary referral center, analyzing data from January 2022 to December 2022.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placenta Accreta Spectrum Group | – | Diagnostic Test: relaxin* 20 patients diagnosed with PAS, confirmed through histopathological findings post-cesarean hysterectomy * Blood and placental tissue analyzed for relaxin levels and placental volume * Subgroup analysis based on PAS severity (accreta, increta, percreta) |
| Control Group (No PAS Pathology with Elective Cesarean Section) | – | Diagnostic Test: relaxin* 20 healthy pregnant women undergoing elective cesarean section * Blood and placental volume assessed |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of two groups. Following retrospective investigation of patients operated in our clinic between 01.01.2022 and 01.12.2022, the case group included 20 patients diagnosed with PAS disorders, suspected with clinical and imaging findings, confirmed through histopathological findings. These patients had undergone elective cesarean hysterectomy and met inclusion criteria aged between 18 and 45 years and availability of complete medical records. Due to ethical considerations, 4 patients diagnosed with PAS who underwent emergency surgery because of vaginal bleeding and 14 patients operated with segmentary resections were excluded from the study to compose more homogenous study cohort for the measurement of EPV. The control group consisted of 20 healthy pregnant women who underwent the first planned cesarean section of the day, without any obstetric complications, on the same days when planned PAS cesarean-hysterectomy cases were performed in 2022.
Key inclusion criteria (4 listed)
- Women aged 18-45 years
- Confirmed histopathological diagnosis of PAS (case group)
- Complete medical records
- Healthy pregnant women undergoing cesarean delivery (control group)
Key exclusion criteria (3 listed)
- Multifetal gestation
- Emergency surgeries
- Incomplete medical records
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 |
|---|---|---|
| relaxinThe primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altCirculating relaxin levels were assessed before routinely storing maternal venous blood and umbilical cord arterial blood samples are anelyzed. This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta). | Diagnostic test | Control Group (No PAS Pathology with Elective Cesarean Section), Placenta Accreta Spectrum Group |
Primary outcome
Circulating relaxin (RLN2) levels in peripheral and umbilical cord blood
Time frame: 11 months
The primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altered expression of relaxin, its receptor RXFP1, and insulin-like peptide 4 (INSL4) in PAS cases, suggesting potential roles in its pathogenesis.
1 secondary outcome
placental volume
Time frame: 11 months
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 30 Sep 2026.
- Background: PubMed 33561012Burston HE, Kent OA, Communal L, Udaskin ML, Sun RX, Brown KR, Jung E, Francis KE, La Rose J, Lowitz J, Drapkin R, Mes-Masson AM, Rottapel R. Inhibition of relaxin autocrine signaling confers therapeutic vulnerability in ovarian cancer. J Clin Invest. 2021 Apr 1;131(7):e142677. doi: 10.1172/JCI142677.
- Background: PubMed 39483207Ma P, Hu T, Chen Y. The Association and diagnostic value between Maternal Serum Placental Markers and Placenta Previa. Eur J Obstet Gynecol Reprod Biol X. 2024 Oct 11;24:100346. doi: 10.1016/j.eurox.2024.100346. eCollection 2024 Dec.
- Background: PubMed 27922185Patil NA, Rosengren KJ, Separovic F, Wade JD, Bathgate RAD, Hossain MA. Relaxin family peptides: structure-activity relationship studies. Br J Pharmacol. 2017 May;174(10):950-961. doi: 10.1111/bph.13684. Epub 2017 Jan 19.
- Results publication: PubMed 23302396Goh W, Yamamoto SY, Thompson KS, Bryant-Greenwood GD. Relaxin, its receptor (RXFP1), and insulin-like peptide 4 expression through gestation and in placenta accreta. Reprod Sci. 2013 Aug;20(8):968-80. doi: 10.1177/1933719112472735. Epub 2013 Jan 9.
- 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 Accreta Spectrum and Placenta Accreta / Percreta, run by Başakşehir Çam & Sakura City Hospital 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 4 inclusion and 3 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 30 Sep 2026. 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?
Circulating relaxin (RLN2) levels in peripheral and umbilical cord blood (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06808165, which also lists 4 linked publications.
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 30 Sep 2026.