Clinical trial NCT05542043: Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta
Official title: Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage (PPH)
Placental Dysfunction
Keywords: Placenta Histology
Placenta accreta
Placenta increta
Placenta percreta
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 2348
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Number of Placenta praevia
timeFrame: one time assessment at baseline
measure: Number of Caesarean sections
timeFrame: one time assessment at baseline
measure: Number of women with obesity
timeFrame: one time assessment at baseline
measure: Increased maternal age
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine
Study officials:
affiliation: University Hospital Basel, Women's Clinic
name: Irene Hoesli, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: