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Completed

NCT Number: NCT06808165

Relaxin and Placental Volume in Placenta Accreta Spectrum

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Multifetal gestation Emergency surgeries Incomplete medical records

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. placental volume

    Time frame: 11 months

    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.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Evaluation of Relaxin and Placental Volume in Placenta Accreta Spectrum Disorders: A Case-Control Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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