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Clinical Trials/NCT05542043
NCT05542043
Completed
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country2,348 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Hemorrhage (PPH)
Sponsor
University Hospital, Basel, Switzerland
Enrollment
2348
Locations
1
Primary Endpoint
Number of Placenta praevia
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
October 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Placenta praevia

Time Frame: one time assessment at baseline

Descriptive analysis: Number of women with Placenta praevia (in women with PPH (blood loss ≥ 500 ml) compared to women with normal blood loss (\< 500 ml))

Number of women with obesity

Time Frame: one time assessment at baseline

Descriptive analysis: Number of pregnant women with obesity (in women with PPH (blood loss ≥ 500 ml) compared to women with normal blood loss (\< 500 ml))

Increased maternal age

Time Frame: one time assessment at baseline

Descriptive analysis: Number of pregnant women with increased maternal age (in women with PPH (blood loss ≥ 500 ml) compared to women with normal blood loss (\< 500 ml))

Number of Caesarean sections

Time Frame: one time assessment at baseline

Descriptive analysis: Number of women with Caesarean section (in women with PPH (blood loss ≥ 500 ml) compared to women with normal blood loss (\< 500 ml))

Study Sites (1)

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