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CompletedNCT05542043Updated Dec 7, 2022

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

An observational study in Postpartum Hemorrhage (PPH) and Placental Dysfunction, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,348
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Postpartum Hemorrhage (PPH)
  • Placental Dysfunction

Keywords

  • Placenta Histology
  • Placenta accreta
  • Placenta increta
  • Placenta percreta
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In context

Postpartum Hemorrhage

456 studies on the registry are indexed under Postpartum Hemorrhage; 77 are open to participants now.

This study's enrollment of 2,348 is above the median of 169 across 94 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Existence of a documented refusal
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,348 participants (actual)
Patient registry
No

Groups and cohorts

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

    Other: Data collection

  • Women with increased blood loss (BV ≥ 500 mL)

    Other: Data collection

Interventions

  • OtherData 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.

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What researchers measure

Primary outcomes

  1. 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))

    Time frame: one time assessment at baseline

  2. 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))

    Time frame: one time assessment at baseline

  3. 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))

    Time frame: one time assessment at baseline

  4. 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))

    Time frame: one time assessment at baseline

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Study locations

1 site
  • University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine
    Basel, 4031, Switzerland
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References and documents

Publications

  • 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. PubMed 37951863 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05542043
Responsible party
Sponsor
First posted
Sep 15, 2022
Start date
Jul 1, 2020
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Dec 7, 2022

Study contacts

Irene Hoesli, Prof. Dr. med.
principal investigator · University Hospital Basel, Women's Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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