Postpartum Hemorrhage Clinical Trial
— SPPHOfficial title:
Incidence and Risk Factors for Secondary Severe Postpartum Hemorrhage in the General Population
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality and morbidity worldwide, including in France, where it accounts for approximately 20% of maternal mortality. Although numerous studies have examined immediate PPH, very few have explored secondary (also called late) PPH. Moreover, there are no guidelines in France for the management of secondary PPH. Its frequency appears to vary from 0.2% to 3.0% of deliveries. It is, however, difficult to estimate because only severe secondary PPH will lead to hospitalization and the rare publications concern single-center studies. The cause of these secondary hemorrhages is often unknown, due to the lack of routine uterine aspiration. Nonetheless, this aspiration is not always medically justified. The principal objective of this study is thus to establish the incidence of severe late PPH in the general population.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years to 55 Years |
Eligibility |
Inclusion Criteria: - All women presenting a severe secondary postpartum hemorrhage, defined as a genital hemorrhage (intra-abdominal or exteriorized vaginally) between 24 hours and 42 days (6 weeks) after childbirth and requiring either rehospitalization or a medical or interventional procedure during the postpartum hospitalization (medication, vascular embolization, and/or surgical procedures). Women with several episodes of severe secondary postpartum hemorrhage during the 42 days postpartum will be included only once. Exclusion Criteria: - - All women with an immediate PPH, defined as a hemorrhage in the 24 hours after delivery, unassociated with a secondary PPH. - All women who did not give birth in Auvergne. - All women who returned home after delivery without any medical or interventional procedure during the postpartum hospitalization, with a hemorrhage in the 42 days after delivery, but not rehospitalized, regardless of whether they sought care in an emergency department. |
Country | Name | City | State |
---|---|---|---|
France | Ch Aurillac | Aurillac | |
France | Clinique La Chataigneraie | Beaumont | |
France | Chu Clermont-Ferrand | Clermont-Ferrand | |
France | Ch Issoire | Issoire | |
France | CH PUY | Le Puy-en-Velay | |
France | Ch Montlucon | Montluçon | |
France | Ch Moulins | Moulins | |
France | CH Saint-Flour | Saint-Flour | |
France | Ch Thiers | Thiers | |
France | CH VICHY | Vichy |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | AUDIPOG, CH d’Aurillac, CH d’Issoire, CH de Montluçon, CH de Moulins, CH de Saint-Flour, CH de Thiers, CH du Puy-en-Velay, CRRF La Châtaigneraie, Jacques Lacarin Hospital Center, Université d'Auvergne |
France,
Debost-Legrand A, Rivière O, Dossou M, Vendittelli F. Risk Factors for Severe Secondary Postpartum Hemorrhages: A Historical Cohort Study. Birth. 2015 Sep;42(3):235-41. doi: 10.1111/birt.12175. Epub 2015 May 29. — View Citation
Dewhurst CJ. Secondary post-partum haemorrhage. J Obstet Gynaecol Br Commonw. 1966 Feb;73(1):53-8. — View Citation
Dossou M, Debost-Legrand A, Déchelotte P, Lémery D, Vendittelli F. Severe secondary postpartum hemorrhage: a historical cohort. Birth. 2015 Jun;42(2):149-55. doi: 10.1111/birt.12164. Epub 2015 Apr 13. — View Citation
Hoveyda F, MacKenzie IZ. Secondary postpartum haemorrhage: incidence, morbidity and current management. BJOG. 2001 Sep;108(9):927-30. — View Citation
King PA, Duthie SJ, Dong ZG, Ma HK. Secondary postpartum haemorrhage. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):394-8. — View Citation
Vendittelli F, Dossou M, Debost-Legrand A, Déchelotte P, Lémery D. Reply. Birth. 2016 Jun;43(2):185-6. doi: 10.1111/birt.12224. — View Citation
Vendittelli F, Savary D, Storme B, Rieu V, Chabrot P, Charpy C, Lémery D, Jacquetin B. Ovarian thrombosis and uterine synechiae after arterial embolization for a late postpartum haemorrhage. Case Rep Womens Health. 2014 Nov 22;5:1-4. doi: 10.1016/j.crwh.2014.10.001. eCollection 2015 Jan. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of severe secondary PPH in the general population | Severe secondary PPH is defined as a genital hemorrhage between Day 1 and Day 42 (6 weeks) after childbirth and requiring hospitalization | between Day 1 and Day 42 | |
Secondary | Identification of the risk factors for severe late PPH. | The secondary outcome criteria will be to identify the medical risk factors for severe late PPH. | at day 1 | |
Secondary | Identification of the management protocols most appropriate for women determined to be at risk of severe late PPH | Collection from the medical files of the procedures used for PPH management of the women included (medical, surgical, radiological, etc.). | at day 1 |
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