Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta

NCT ID: NCT05542043

Last Updated: 2022-12-07

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

2348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-10-31

Brief Summary

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This retrospective, monocentric study aims to examine risk factors for postpartum hemorrhage in women with histologically verified placenta accreta. Women with histologically verified placenta accreta are divided into two groups: women with normal blood loss (BV \< 500 ml) versus women with increased blood loss (BV ≥ 500 ml). The clinical data of pregnant women with histologically verified placental disorders, who gave birth in the Women's Clinic University Hospital Basel (USB) between 1986 and 2019, are compared with each other.

Detailed Description

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Placental disorders are defined as abnormal implantation of the placenta due to a defect in the basal decidua. Depending on the severity of the incorrect implantation, three different stages can be distinguished (placenta accreta, increta and percreta). Placentation disorders are reported in the literature with an increasing frequency of up to 3%. In the last 10 years, the incidence has increased 10-fold and currently affects 1 to 80 out of 2500 births, depending on the literature. Not every histologically verified placental disorder is associated with postpartum hemorrhage. According to the World Health Organization (WHO), postpartum hemorrhage (PPH) is defined as blood loss ≥ 500 ml within 24 hours after delivery. This retrospective, monocentric study aims to examine risk factors for postpartum hemorrhage in women with histologically verified placenta accreta. Women with histologically verified placenta accreta are divided into two groups: women with normal blood loss (BV \< 500 ml) versus women with increased blood loss (BV ≥ 500 ml). The clinical data of pregnant women with histologically verified placental disorders, who gave birth in the Women's Clinic USB between 1986 and 2019, are compared with each other.

Conditions

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Postpartum Hemorrhage (PPH) Placental Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women with normal blood loss (BV < 500 mL)

Data collection

Intervention Type OTHER

The data includes anamnestic and clinical data from women whose placental histology reveals a diagnosis of placental dysfunction.

Maternal data on the following characteristics: age, ethnicity, BMI, pregnancy, parity, number of abortions without curettage, multiple births, previous birth mode.

Risk factors for placentation disorders (increased maternal age, increased pregnancy and parity, increased BMI, placenta previa, nicotine abuse, multiple births, hypertension, diabetes, infections, bleeding, abortion curettage, hysteroscopy ± cavum curettage, caesarean section, fibroid removal, Asherman' s syndrome, status after IVF, endometritis) and birth mode.

Data on peripartal and postpartum surgical measures.

Women with increased blood loss (BV ≥ 500 mL)

Data collection

Intervention Type OTHER

The data includes anamnestic and clinical data from women whose placental histology reveals a diagnosis of placental dysfunction.

Maternal data on the following characteristics: age, ethnicity, BMI, pregnancy, parity, number of abortions without curettage, multiple births, previous birth mode.

Risk factors for placentation disorders (increased maternal age, increased pregnancy and parity, increased BMI, placenta previa, nicotine abuse, multiple births, hypertension, diabetes, infections, bleeding, abortion curettage, hysteroscopy ± cavum curettage, caesarean section, fibroid removal, Asherman' s syndrome, status after IVF, endometritis) and birth mode.

Data on peripartal and postpartum surgical measures.

Interventions

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Data collection

The data includes anamnestic and clinical data from women whose placental histology reveals a diagnosis of placental dysfunction.

Maternal data on the following characteristics: age, ethnicity, BMI, pregnancy, parity, number of abortions without curettage, multiple births, previous birth mode.

Risk factors for placentation disorders (increased maternal age, increased pregnancy and parity, increased BMI, placenta previa, nicotine abuse, multiple births, hypertension, diabetes, infections, bleeding, abortion curettage, hysteroscopy ± cavum curettage, caesarean section, fibroid removal, Asherman' s syndrome, status after IVF, endometritis) and birth mode.

Data on peripartal and postpartum surgical measures.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with a histologically verified placental disorder who gave birth at the Women's Hospital USB between 1986 and 2019

Exclusion Criteria

* Existence of a documented refusal
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene Hoesli, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Women's Clinic

Locations

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University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Ghaem Maghami N, Helfenstein F, Manegold-Brauer G, Amstad G. Risk factors for postpartum haemorrhage in women with histologically verified placenta accreta spectrum disorders: a retrospective single-centre cross-sectional study. BMC Pregnancy Childbirth. 2023 Nov 11;23(1):786. doi: 10.1186/s12884-023-06103-5.

Reference Type DERIVED
PMID: 37951863 (View on PubMed)

Other Identifiers

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2020-01047; sp20Ghaemmaghami

Identifier Type: -

Identifier Source: org_study_id

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