NCT00928863

Brief Summary

The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Second to study barriers and facilitators for guideline adherence and to develop and test a tailored implementation strategy, based on these findings.

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
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

3.6 years

First QC Date

June 25, 2009

Last Update Submit

May 22, 2013

Conditions

Keywords

haemorrhagia postpartumimplementation guidelinesmaternal morbiditymanagement of obstetrics and trauma

Outcome Measures

Primary Outcomes (3)

  • actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions).

    1 year

  • feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators.

    1 years

  • barrier analysis

    the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators

    1 year

Secondary Outcomes (2)

  • actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care.

    1 year

  • feasibility study: the secondary outcome measures are the experiences of professionals and patients with the different elements of the implementation strategy and the changed care, and the cost of the tested strategy.

    1 year

Study Arms (1)

Haemorrhagia post partum

Women with a high risk for haemorrhagia post partum.

Other: implementation aids

Interventions

testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals

Haemorrhagia post partum

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women with a high risk for haemorrhagia postpartum delivering in a hospital

You may qualify if:

  • woman with a high risk for haemorrhagia post partum

You may not qualify if:

  • woman who refuses to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (5)

  • Woiski M, de Visser S, van Vugt H, Dijkman A, Schuitemaker N, van Meir C, Middeldorp J, Huisjes A, Mol BW, Molkenboer J, Moonen-Delarue D, Oudijk M, van Rheenen-Flach L, Rijnders R, Pernet P, Porath M, de Wit S, Grol R, Scheepers H, Hermens R. Evaluating Adherence to Guideline-Based Quality Indicators for Postpartum Hemorrhage Care in the Netherlands Using Video Analysis. Obstet Gynecol. 2018 Sep;132(3):656-667. doi: 10.1097/AOG.0000000000002781.

  • de Visser SM, Woiski MD, Grol RP, Vandenbussche FPHA, Hulscher MEJL, Scheepers HCJ, Hermens RPMG. Development of a tailored strategy to improve postpartum hemorrhage guideline adherence. BMC Pregnancy Childbirth. 2018 Feb 8;18(1):49. doi: 10.1186/s12884-018-1676-6.

  • Woiski MD, van Vugt HC, Dijkman A, Grol RP, Marcus A, Middeldorp JM, Mol BW, Mols F, Oudijk MA, Porath M, Scheepers HJ, Hermens RP. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality. Matern Child Health J. 2016 Oct;20(10):2160-8. doi: 10.1007/s10995-016-2050-9.

  • Woiski MD, Belfroid E, Liefers J, Grol RP, Scheepers HC, Hermens RP. Influencing factors for high quality care on postpartum haemorrhage in the Netherlands: patient and professional perspectives. BMC Pregnancy Childbirth. 2015 Oct 23;15:272. doi: 10.1186/s12884-015-0707-9.

  • Woiski MD, Hermens RP, Middeldorp JM, Kremer JA, Marcus MA, Wouters MG, Grol RP, Lotgering FK, Scheepers HC. Haemorrhagia post partum; an implementation study on the evidence-based guideline of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Managing Obstetric Emergencies and Trauma-course) instructions; the Fluxim study. BMC Pregnancy Childbirth. 2010 Jan 26;10:5. doi: 10.1186/1471-2393-10-5.

MeSH Terms

Conditions

Postpartum HemorrhageWounds and Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rosella Hermens, PhD

    IQ healthcare, Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

January 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations