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

Placental Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542043
• Other study ID #: 2020-01047; sp20Ghaemmaghami
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2348
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Placenta Accreta
• Postpartum Hemorrhage
• Postpartum Hemorrhage (PPH)

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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