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Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version.

Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22365
Enrollment
50
Registered
2009-06-26
Start date
2009-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implementation of external cephalic version in obstetric care in The Netherlands.

Interventions

In the first two phases of the study, a omplementation plan will be developed. The regions of the participating hospitals will be randomized either to the control group, or to the group starting to wo

Sponsors

Prof. dr. BW Mol Academic Medical Center dept. obstetrics & gynaecology, Room H4-213 Meibergdreef 9 1105 AZ Amsterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The proposal will contain three phases. In the first phase, we will identify facilitators and barriers of implementation of ECV. Subsequently, we will develop an implementation strategy targeted on patient counselling and information of health care providers, and evaluate the cost-effectiveness of the developed strategy. All hopsitals in midwife practices in The Netherlands are potential candidates for the randomized controlled trial of the implementation developes model.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Secondary

MeasureTime frame
Secondary endpoints are guidelines’ adherence rates, complications at ECV, the number of children that is in cephalic position at delivery, the number of caesarean sections and the perinatal condition of mother and child. Moreover, we will assess patient knowledge (e.g. ECV, breech delivery, caesarean section), patient decisional conflict and patient satisfaction. We will also calculate costs of both implementation interventions and medical interventions. In case one or both implementation interventions are effective, their cost-effectiveness will be assessed.

Primary

MeasureTime frame
Primary endpoint is the number of patients that has an ECV performed.

Contacts

Public ContactF. Vlemmix

Academic Medical Center (AMC) Dept Gynaecology & Obstetrics, H4-140.1 Meibergdreef 8

F.Vlemmix@amc.uva.nl, f.vlemmix@gmail.com+31-(0)20-5666199

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)