Relaxin and Placental Volume in Placenta Accreta Spectrum

NCT ID: NCT06808165

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-01-01

Brief Summary

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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

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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.

Conditions

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Placenta Accreta Spectrum Placenta Accreta / Percreta

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

relaxin

Intervention Type 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)

* 20 healthy pregnant women undergoing elective cesarean section
* Blood and placental volume assessed

relaxin

Intervention Type 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).

Interventions

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relaxin

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Basaksehir Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33561012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39483207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27922185 (View on PubMed)

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.

Reference Type RESULT
PMID: 23302396 (View on PubMed)

Other Identifiers

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KAEK/2023.01.20

Identifier Type: -

Identifier Source: org_study_id

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