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Home or Hospital Birth, Does It Really Matter? A Randomised Controlled Trial - Article


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Clinical Trial: Home or Hospital Birth, Does It Really Matter? A Randomised Controlled Trial

This study is not yet open for patient recruitment.
Verified by University of Maastricht January 2005

Sponsors and Collaborators: Academic Hospital Maastricht
School for Midwifery Maastricht
University of Maastricht
Information provided by: University of Maastricht
ClinicalTrials.gov Identifier: NCT00237601

Purpose

In the Netherlands, which has about 200.000 births per year, maternity care is provided by midwives or general practitioners unless medical reasons necessitate specialist obstetric care. Women with low risk pregnancies are free to decide where to give birth, attended by their midwife or general practitioner, at home or in the hospital, from which they are then discharged within 24 hours. In the Netherlands these hospital births are referred to as “poliklinische bevallingen“ (i.e. outpatient deliveries) to indicate that they do not involve formal hospitalisation, or as “verplaatste thuisbevalling” (i.e. relocated home births) to indicate that they are supervised by the same caregivers as the home births without involvement of specialist obstetricians.

In the last two decades a marked increase in the referral rate to obstetricians during childbirth has occurred, especially for nulliparae, both in planned home births and planned hospital births (outpatient deliveries). 90% from all primigravidae will start their pregnancy under care of the primary caregiver (midwife of general practitioner). During the pregnancy 30% will be referred to the secondary caregiver (obstetrician specialist). The other 60% will start labor guided by the primary caregiver. More than 50% of these women will be referred to the obstetrician during labor.

Despite this unique situation of the Dutch maternity care, the differences between home and hospital birth (outpatient deliveries) with regard to effectivity and efficiency have never been investigated. It is also unclear if pregnant women are informed about a 50% risk of being transported to the secondary caregiver/ hospital during labor at home. Neitehr do we know what their experiences are.

This study aims to investigate the differences between home and hospital deliveries under care of the primary caregiver with regard to effectivity (costs) and efficiency (patient satisfaction) of care.

Condition Intervention Phase
Pregnancy
 Procedure: obstetric care
Phase III

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening, Longitudinal, Random Sample, Prospective Study

Further study details as provided by University of Maastricht:

Expected Total Enrollment:  1200

Study start: January 2006;  Expected completion: December 2008
Last follow-up: December 2007;  Data entry closure: December 2007

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • Primiparae
  • No medical indication for specialistic care
  • The pregnant woman will be able to give birth at home or at a hospital
  • The woman and her partner will be fluent in the Dutch language

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00237601

Jan G. Nijhuis, prof dr MD Phd      0031-43-3874768    jnij@sgyn.azm.nl
Marijke JC Hendrix, MBA      0031-46-4527228    mhendrix@wanadoo.nl

Netherlands, Limburg
      Academic Hospital Maastricht, Maastricht,  Limburg,  6136AB,  Netherlands

Study chairs or principal investigators

Jan G. Nijhuis, Prof dr MD PhD,  Study Chair,  Academic Hospital Maastricht   
Marijke JC Hendrix, MBA,  Principal Investigator,  Academic Hospital Maastricht   

More Information

Study ID Numbers:  PF 198
Last Updated:  December 8, 2005
Record first received:  October 7, 2005
ClinicalTrials.gov Identifier:  NCT00237601
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
ClinicalTrials.gov processed this record on 2006-01-10

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Page Updated: September 6, 2005
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