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

Completed

• Conditions: Placental Dysfunction; Postpartum Hemorrhage (PPH)
• Interventions: Other: Data collection

• Registration Number: NCT05542043
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2348

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with normal blood loss (BV < 500 mL)	Data collection	-
Women with increased blood loss (BV ≥ 500 mL)	Data collection	-

Primary Outcome Measures

Name	Time	Method
Number of Placenta praevia	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	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	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	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))

Trial Locations

Locations (1)

University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine; 🇨🇭 Basel, Switzerland