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CompletedNCT06808165Updated Sep 30, 2026

Relaxin and Placental Volume in Placenta Accreta Spectrum

An observational study in Placenta Accreta Spectrum and Placenta Accreta / Percreta, sponsored by Başakşehir Çam & Sakura City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

Updated Sep 30, 2026First site in Turkey (Türkiye)No longer in Turkey+3 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
40
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Placenta Accreta Spectrum
  • Placenta Accreta / Percreta

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Keywords

  • Biomarker
  • PAS
  • Placenta Accreta Spectrum
  • Placental Volume
  • Relaxin
  • RLN2
03

In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

This study's enrollment of 40 is below the median of 84 across 79 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 105 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Inclusion criteria

Women aged 18-45 years

Confirmed histopathological diagnosis of PAS (case group)

Complete medical records

Healthy pregnant women undergoing cesarean delivery (control group)

Exclusion criteria

Exclusion Criteria:

Multifetal gestation

Emergency surgeries

Incomplete medical records

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

    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

    Diagnostic Test: relaxin

Interventions

  • Diagnostic testrelaxin

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 11 months

07

Study locations

1 site
  • Basaksehir Cam and Sakura City Hospital
    Istanbul, Turkey, Turkey (Türkiye)
08

References and documents

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 33561012 ↗
  • Ma 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 39483207 ↗
  • Patil 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 27922185 ↗
  • Goh 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 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed — first site in Turkey (Türkiye); no longer in Turkey
Show site
  • Basaksehir Cam and Sakura City Hospital · Istanbul, Turkey (Türkiye)
Show 1 removed
  • Basaksehir Cam and Sakura City Hospital · İstanbul, Turkey
Sep 30, 2026
Also revised
eligibility
Show all 1 update
  1. Sep 30, 2026
    1 site added, 1 site removed — first site in Turkey (Türkiye); no longer in Turkey
    Show site
    • Basaksehir Cam and Sakura City Hospital · Istanbul, Turkey (Türkiye)
    Show 1 removed
    • Basaksehir Cam and Sakura City Hospital · İstanbul, Turkey
    Eligibility Criteria revised
    + 1 other change: index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06808165
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Responsible party
Sponsor
First posted
Feb 5, 2025
Start date
Jan 1, 2022
Primary completion
Nov 1, 2022
Completion
Jan 1, 2023
Last update
Sep 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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