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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage (PPH); Placental Dysfunction
• Intervention / Treatment: Other: Data collection

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 Type: Observational
• Enrollment (Actual): 2348

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women with histologically verified placental disorder who gave birth in the USB women's clinic between 1986 and 2019.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with normal blood loss (BV < 500 mL)	Other: 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.
Women with increased blood loss (BV ≥ 500 mL)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Placenta praevia	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))	one time assessment at baseline
Number of Caesarean sections	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))	one time assessment at baseline
Number of women with obesity	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))	one time assessment at baseline
Increased maternal age	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))	one time assessment at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Irene Hoesli, Prof. Dr. med., University Hospital Basel, Women's Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Placenta Histology; Placenta accreta; Placenta increta; Placenta percreta
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Placenta Accreta
• Other Study ID Numbers: 2020-01047; sp20Ghaemmaghami

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No