NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL

NCT04723979 | Completed

• 2 other identifiers: ClinEpi_SC_41493TRIAL NL3909 (NTR4079)
• Study Type: observational
• Target: 3,322
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this project is to include currently available information from women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® and to examine whether NovoSeven® may have affected the course of the PPH in these women, specifically the control of bleeding. Data will be included from previous cohort studies from four countries: United Kingdom (UK), the Netherlands, Denmark, and France.

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Occurrence of invasive procedures (yes/no)

  Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy. Time0 is defined as time of first administration of NovoSeven®. It occurs x minutes after onset of sPPH. For matched controls: Time0 is derived from the matching process. It is equal to the period from onset of sPPH to time of first administration of NovoSeven® for the patient for which they are a matched control.

  20 minutes - 24 hours following time_zero

Secondary Outcomes (4)

• Occurrence of thromboembolic events, yes/no

  From time_zero until 5 days after time_zero

• Amount of blood products transfused

  From birth to 24 hours after time_zero

• Estimated blood loss

  From birth to 24 hours after time_zero

• Occurrence of hysterectomy, yes/no

  20 minutes - 24 hours following time_zero

Study Arms (2)

Exposed to recombinant FVIIa (NovoSeven®)

all women exposed to NovoSeven® during sPPH

Drug: Eptacog alfa; Other: Standard of care

Standard of Care

Women with postpartum hemorrhage not exposed to NovoSeven®.

Other: Standard of care

Interventions

Eptacog alfa DRUG

Recombinant coagulation factor VII activated

Also known as: NovoSeven, recombinant FVIIa

Exposed to recombinant FVIIa (NovoSeven®)

Standard of care OTHER

Patients have been treated according to local routine clinical practice at the discretion of the treating physician.

Exposed to recombinant FVIIa (NovoSeven®); Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective study of women treated for severe postpartum hemorrhage (sPPH) during normal clinical practice. The study population underwent treatment for sPPH during the country specific study periods. They are followed from time of diagnosis of sPPH until end of hospitalisation.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Novo Nordisk A/S: collaborator
• Herlev Hospital: collaborator
• University of Oxford: collaborator
• VU University of Amsterdam: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Publications (4)

• Edwards HM. Aetiology and treatment of severe postpartum haemorrhage. Dan Med J. 2018 Mar;65(3):B5444.

  PMID: 29510809 BACKGROUND

• Deneux-Tharaux C, Morau E, Dreyfus M; pour le Cnemm. [Maternal mortality in France 2013-2015: An evolving profile]. Gynecol Obstet Fertil Senol. 2021 Jan;49(1):1-2. doi: 10.1016/j.gofs.2020.12.002. No abstract available. French.

  PMID: 33423750 BACKGROUND

• Henriquez DDCA, Caram-Deelder C, le Cessie S, Zwart JJ, van Roosmalen JJM, Eikenboom JCJ, So-Osman C, van de Watering LMG, Zwaginga JJ, Koopman-van Gemert AWMM, Bloemenkamp KWM, van der Bom JG; TeMpOH-1 Research Group. Association of Timing of Plasma Transfusion With Adverse Maternal Outcomes in Women With Persistent Postpartum Hemorrhage. JAMA Netw Open. 2019 Nov 1;2(11):e1915628. doi: 10.1001/jamanetworkopen.2019.15628.

  PMID: 31730187 BACKGROUND

• Henriquez DDCA, Bloemenkamp KWM, Loeff RM, Zwart JJ, van Roosmalen JJM, Zwaginga JJ, van der Bom JG; TeMpOH-1 study group. Fluid resuscitation during persistent postpartum haemorrhage and maternal outcome: A nationwide cohort study. Eur J Obstet Gynecol Reprod Biol. 2019 Apr;235:49-56. doi: 10.1016/j.ejogrb.2019.01.027. Epub 2019 Feb 4.

  PMID: 30784827 BACKGROUND

Related Links

• UKOSS Major Obstetric Haemorrhage

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

recombinant FVIIa; Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Johanna G van der Bom, MD, PhD

  Leiden University Medical Center, Netherlands

  STUDY CHAIR

• Hellen Edwards, MD, PhD

  Herlev University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

• Catherine Deneux-Tharaux, MD, PhD

  INSERM, France

  PRINCIPAL INVESTIGATOR

• Marian Knight, MD, PhD

  University of Oxford, UK

  PRINCIPAL INVESTIGATOR

• Camilla Birkegård, PhD

  Novo Nordisk A/S

  STUDY DIRECTOR

• Nan van Geloven, PhD

  Leiden University Medical Center, Netherlands

  PRINCIPAL INVESTIGATOR

• Dacia Henriquez, MD, PhD

  Amsterdam UMC, Netherlands

  PRINCIPAL INVESTIGATOR

• Thomas van den Akker, MD, PhD

  Leiden University Medical Center, Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Epidemiology

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: May 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 31, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)