NCT03840889

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

January 31, 2019

Last Update Submit

February 12, 2019

Conditions

Postpartum HemorrhageMaternal MorbidityRetained PlacentaPostpartum EndometritisDelivery

Keywords

Prospective cohortPopulation-based studyMulticenter studyMaternity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Identification of the risk factors for severe late PPH.

    at day 1

  • Identification of the management protocols most appropriate for women determined to be at risk of severe late PPH

    at day 1

Study Arms (1)

Women with a severe late PPH

Women with a severe late PPH will be recruited prospectively after verification of the inclusion criteria by a gynecologist-obstetrician or the investigating midwives, who will provide the patients information about the study and include them unless they object

Other: Data collection

Interventions

Data collectionOTHER

he different modes of active data collection: * Data collection by telephone * Data collection by mail * Collection from discharge database summaries (PMSI)

Women with a severe late PPH

Eligibility Criteria

Age12 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All women presenting a severe secondary postpartum hemorrhage

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ch Aurillac

Aurillac, France

Location

Clinique La Chataigneraie

Beaumont, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Ch Issoire

Issoire, France

Location

CH PUY

Le Puy-en-Velay, France

Location

Ch Montlucon

Montluçon, France

Location

Ch Moulins

Moulins, France

Location

CH Saint-Flour

Saint-Flour, France

Location

Ch Thiers

Thiers, France

Location

CH VICHY

Vichy, France

Location

Related Publications (7)

  • Dewhurst CJ. Secondary post-partum haemorrhage. J Obstet Gynaecol Br Commonw. 1966 Feb;73(1):53-8. doi: 10.1111/j.1471-0528.1966.tb05120.x. No abstract available.

    PMID: 5295509BACKGROUND

  • King PA, Duthie SJ, Dong ZG, Ma HK. Secondary postpartum haemorrhage. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):394-8. doi: 10.1111/j.1479-828x.1989.tb01776.x.

    PMID: 2631675BACKGROUND

  • Hoveyda F, MacKenzie IZ. Secondary postpartum haemorrhage: incidence, morbidity and current management. BJOG. 2001 Sep;108(9):927-30. doi: 10.1111/j.1471-0528.2001.00230.x.

    PMID: 11563461BACKGROUND

  • Dossou M, Debost-Legrand A, Dechelotte P, Lemery 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.

    PMID: 25867033BACKGROUND

  • Vendittelli F, Dossou M, Debost-Legrand A, Dechelotte P, Lemery D. Reply. Birth. 2016 Jun;43(2):185-6. doi: 10.1111/birt.12224. No abstract available.

    PMID: 27160377BACKGROUND

  • Vendittelli F, Savary D, Storme B, Rieu V, Chabrot P, Charpy C, Lemery 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.

    PMID: 29594009BACKGROUND

  • Debost-Legrand A, Riviere 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.

    PMID: 26032774BACKGROUND

MeSH Terms

Conditions

Postpartum HemorrhagePlacenta, Retained

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPlacenta Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Françoise VENDITELLI

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

04 73 75 49 63drci@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 15, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

FR(10)