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Home or Hospital Birth, Does it Really Matter? A Randomised Controlled Trial
This study is currently recruiting participants.
Verified by Maastricht University Medical Center, June 2007
Sponsors and Collaborators: Maastricht University Medical Center
School for Midwifery Maastricht
Information provided by: Maastricht University Medical Center
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. Neither 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 related topics: Caregivers
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Random Sample, Prospective Study

Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment: 1200
Study Start Date: January 2006
Estimated Study Completion Date: December 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237601

Contacts
Contact: Jan G. Nijhuis, MD Phd 0031-43-3874768 jnij@sgyn.azm.nl
Contact: Marijke JC Hendrix, MSc 0031-43-3871042 mhendrix@ved2.azm.nl

Locations
Netherlands
Academic Hospital Maastricht Recruiting
Maastricht, Netherlands, 6202 HX
Contact: M JC Hendrix, MSc     0031-43-71042     mhendrix@ved2.azm.nl    
Principal Investigator: M JC Hendrix, MSc            
Sponsors and Collaborators
Maastricht University Medical Center
School for Midwifery Maastricht
Investigators
Study Chair: Jan G. Nijhuis, Prof dr MD PhD Maastricht University Medical Center
Principal Investigator: Marijke JC Hendrix, MBA Maastricht University Medical Center
  More Information

Study ID Numbers: PF 198
Study First Received: October 7, 2005
Last Updated: June 6, 2007
ClinicalTrials.gov Identifier: NCT00237601  
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Home birth
Hospital birth
Midwifery
Effectivity
Efficiency

ClinicalTrials.gov processed this record on January 16, 2009