NCT06849349

Brief Summary

Placenta previa can cause a risk of severe bleeding during labor. Placenta previa is usually classified into four different types: total, partial, marginal and asymptomatic. The condition is diagnosed by ultrasonography later in pregnancy and its management varies depending on the location of the placenta and the presence of bleeding. Studies show that the increased frequency of placenta previa is associated with increased cesarean section rates and maternal age (1). Furthermore, the effects of placenta previa on maternal and fetal morbidity can be reduced with proper management (2). Placenta percreata is a condition in which the placenta invades the myometrium (uterine muscle) and serosa (outer surface of the uterus). This can make postpartum detachment of the placenta difficult, leading to severe bleeding and complications. Placenta perforata is often associated with placenta previa and may require surgical intervention. Ultrasonography and magnetic resonance imaging (MRI) are used to diagnose this condition. Risk factors include previous cesarean deliveries and placenta previa (3). Placenta percreata requires careful management as it increases the risk of maternal mortality and morbidity (4). In this study, we aimed to investigate the levels of decorin, laminin, collagen-1, TGFβ-1, PDGF in placentas of pregnant women with placenta percreata and previa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

February 22, 2025

Last Update Submit

May 16, 2026

Conditions

Keywords

Placenta PercreataPlaenta PreviaGLYCOPROTEINFIBERGROWTH FACTORS

Outcome Measures

Primary Outcomes (4)

  • Mean Immunohistochemical Staining Score of Decorin, Laminin, Collagen-I, TGFβ-1, and PDGF in Placenta Percreta Tissues

    Placental tissue samples obtained at delivery from patients with placenta percreta will undergo immunohistochemical staining for decorin, laminin, collagen-I, TGFβ-1, and PDGF. Staining intensity and distribution will be quantified using the H-score method.

    Baseline

  • Maternal and Cord Blood Concentrations of TGFβ-1 and Decorin in Placenta Percreta Pregnancies

    Maternal and cord blood samples collected from pregnancies complicated by placenta percreta will be analyzed for TGFβ-1 and decorin concentrations using biochemical assay methods.

    Baseline

  • Mean Immunohistochemical Staining Score of Decorin, Laminin, Collagen-I, TGFβ-1, and PDGF in Placenta Previa Tissues

    Placental tissue samples obtained at delivery from patients with placenta previa will undergo immunohistochemical staining for decorin, laminin, collagen-I, TGFβ-1, and PDGF. Staining intensity and distribution will be quantified using the H-score method.

    baseline

  • Maternal and Cord Blood Concentrations of TGFβ-1 and Decorin in Placenta Previa Pregnancies

    Maternal and cord blood samples collected from pregnancies complicated by placenta previa will be analyzed for TGFβ-1 and decorin concentrations using biochemical assay methods.

    baseline

Study Arms (3)

Group 1: Pregnant women with Placenta Percreata

Group 2: Pregnant women with Placenta Previa

Group 3: Control

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women of Placenta percreata woman of Placenta previa

You may qualify if:

  • Healthy pregnancy under 37 weeks
  • Age range 18-50
  • Being literate in Turkish
  • Not having any additional disease
  • Agreeing to participate in the study

You may not qualify if:

  • High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.)
  • Multiple pregnancy
  • Pregnant women under the age of 18
  • Smoking
  • Medication use (excluding routinely used food supplements during pregnancy)
  • Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.)
  • Immunosuppressive use
  • Presence of active or chronic infection
  • Presence of active or chronic inflammatory disease
  • Patients who gave birth at an external center or later chose to withdraw from the study
  • Premature birth of patients included in the control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

placenta tissues

MeSH Terms

Conditions

Placenta AccretaPlacenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
11 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2025

First Posted

February 27, 2025

Study Start

February 20, 2025

Primary Completion

June 20, 2025

Study Completion

November 20, 2025

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations