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

NCT05542043 | Completed

• 1 other identifier: 2020-01047; sp20Ghaemmaghami
• Study Type: observational
• Target: 2,348
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage (PPH); Placental Dysfunction

Keywords

Placenta Histology; Placenta accreta; Placenta increta; Placenta percreta

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Women with normal blood loss (BV < 500 mL)

Other: Data collection

Women with increased blood loss (BV ≥ 500 mL)

Other: Data collection

Interventions

Data collection OTHER

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); Women with normal blood loss (BV < 500 mL)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women with a histologically verified placental disorder who gave birth at the Women's Hospital USB between 1986 and 2019

You may not qualify if:

• Existence of a documented refusal

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

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

Basel, 4031, Switzerland

Location

Related Publications (1)

• Ghaem Maghami N, Helfenstein F, Manegold-Brauer G, Amstad G. Risk factors for postpartum haemorrhage in women with histologically verified placenta accreta spectrum disorders: a retrospective single-centre cross-sectional study. BMC Pregnancy Childbirth. 2023 Nov 11;23(1):786. doi: 10.1186/s12884-023-06103-5.

  PMID: 37951863 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Placenta Accreta

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Irene Hoesli, Prof. Dr. med.

  University Hospital Basel, Women's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 15, 2022
• Study Start: July 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CH (1)