Post Partum Hemorrhage Clinical Trial
Official title:
Clinical Use and Outcome of NovoSeven® Treatment in Severe Postpartum Haemorrhage - Experiences From an Observational Multi-country (UK, DK, FR, NL) Retrospective Cohort Study
Verified date | May 2022 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3322 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Inclusion in one of the four cohorts (DK, FR, NL, UK) Exclusion Criteria: - there are no exclusion criteria |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Herlev Hospital, Novo Nordisk A/S, University of Oxford, VU University of Amsterdam |
Netherlands,
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. French. — View Citation
Edwards HM. Aetiology and treatment of severe postpartum haemorrhage. Dan Med J. 2018 Mar;65(3). pii: B5444. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Occurrence of thromboembolic events, yes/no | Count of patients yes/no | From time_zero until 5 days after time_zero | |
Secondary | Amount of blood products transfused | Number of units | From birth to 24 hours after time_zero | |
Secondary | Estimated blood loss | Total volume of blood loss | From birth to 24 hours after time_zero | |
Secondary | Occurrence of hysterectomy, yes/no | count of patients yes/no | 20 minutes - 24 hours following time_zero |
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