Postpartum Hemorrhage (PPH)NCT05542043
Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta
An observational study of Postpartum Hemorrhage (PPH) and Placental Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 ≥… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage (PPH), Placental Dysfunction
- What is being tested?
- Data collection
- How many people
- 2,348 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with histologically verified placental disorder who gave birth in the USB women's clinic between 1986 and 2019.
Who may be able to join
- Pregnant women with a histologically verified placental disorder who gave birth at the Women's Hospital USB between 1986 and 2019
Who cannot join
- Existence of a documented refusal
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Women's Clinic, Obstetrics and pregnancy medicine
Basel, 4031
About this study
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.
- Conditions
- Postpartum Hemorrhage (PPH), Placental Dysfunction
- Being tested
- Data collection
- Keywords
- Placenta Histology, Placenta accreta, Placenta increta, Placenta percreta
- Medical subject headings
- Postpartum Hemorrhage, Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with normal blood loss (BV < 500 mL) | Not described Receives: Other: Data collection | |
| Women with increased blood loss (BV ≥ 500 mL) | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 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))
Measured: 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))
Measured: 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))
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jul 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Hemorrhage (PPH)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Hoesli, Prof. Dr. med., Principal investigator, University Hospital Basel, Women's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542043
- Sponsor's protocol ID
- 2020-01047; sp20Ghaemmaghami
- Status last verified
- Dec 2022
- First submitted
- 5 Sep 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postpartum Hemorrhage in Patients With Histologically Verified Placenta Accreta
- ClinicalTrials.gov ID
- NCT05542043
- Acronym / sponsor ID
- 2020-01047; sp20Ghaemmaghami
- Conditions
- Postpartum Hemorrhage (PPH), Placental Dysfunction
- Keywords
- Placenta Histology, Placenta accreta, Placenta increta, Placenta percreta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,348 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with normal blood loss (BV < 500 mL) | – | Other: Data collection |
| Women with increased blood loss (BV ≥ 500 mL) | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with histologically verified placental disorder who gave birth in the USB women's clinic between 1986 and 2019.
Key inclusion criteria (1 listed)
- Pregnant women with a histologically verified placental disorder who gave birth at the Women's Hospital USB between 1986 and 2019
Key exclusion criteria (1 listed)
- Existence of a documented refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe 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. | Other | Women with increased blood loss (BV ≥ 500 mL), Women with normal blood loss (BV < 500 mL) |
Primary outcome
Number of Placenta praevia
Time frame: one time assessment at baseline
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))
Number of Caesarean sections
Time frame: one time assessment at baseline
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))
Number of women with obesity
Time frame: one time assessment at baseline
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))
Increased maternal age
Time frame: one time assessment at baseline
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))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Derived from this study: PubMed 37951863Ghaem 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Hoesli, Prof. Dr. med. principal investigator
University Hospital Basel, Women's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage (PPH) and Placental Dysfunction, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Placenta praevia (time frame: one time assessment at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.