Relaxin and Placental Volume in Placenta Accreta Spectrum

NCT06808165 | Completed

• 1 other identifier: KAEK/2023.01.20
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placenta Accreta Spectrum; Placenta Accreta / Percreta

Keywords

Biomarker; PAS; Placenta Accreta Spectrum; Placental Volume; Relaxin; RLN2

Outcome Measures

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.

  11 months

Secondary Outcomes (1)

• placental volume

  11 months

Study Arms (2)

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

relaxin DIAGNOSTIC_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).

Control Group (No PAS Pathology with Elective Cesarean Section); Placenta Accreta Spectrum Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: * Women aged 18-45 years * Confirmed histopathological diagnosis of PAS (case group) * Complete medical records * Healthy pregnant women undergoing cesarean delivery (control group)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women aged 18-45 years Confirmed histopathological diagnosis of PAS (case group) Complete medical records Healthy pregnant women undergoing cesarean delivery (control group)

You may not qualify if:

• Multifetal gestation Emergency surgeries Incomplete medical records

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 33561012 BACKGROUND

• 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.

  PMID: 39483207 BACKGROUND

• 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.

  PMID: 27922185 BACKGROUND

• 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.

  PMID: 23302396 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human relaxin-2 (RLN2) levels were measured in maternal serum samples stored at 2-8°C before being discarded, using a Human RLN2 ELISA Kit (Sunred Biological Technology, Shanghai, China) as per the manufacturer's instructions before routinely storing maternal venous blood and umbilical cord arterial blood samples were discarded for legal periods.

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: January 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)