NCT00237601

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 2, 2010

Status Verified

April 1, 2010

Enrollment Period

2.2 years

First QC Date

October 7, 2005

Last Update Submit

April 1, 2010

Conditions

Keywords

Home birthHospital birthMidwiferyEffectivityEfficiency

Outcome Measures

Primary Outcomes (1)

  • primary outcome: referral rate to secondary care, preferences of women and partners with regard to place of birth. Secondary outcome: costs of home birth and hospital births satisfaction of obstetric care

Study Arms (2)

1

Women with the intention to give birth at home

Other: obstetric care

2

Women with the intention to give birth in a short-stay hospital setting

Other: obstetric care

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with a low-risk pregnancy under the care of an independent midwife. Women are free to choose where to give birth, at home or in a short-stay hospital setting. The women are fluent in de Dutch language.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Hospital Maastricht

Maastricht, 6202 HX, Netherlands

Location

Related Publications (1)

  • Aldana-Bitar J, Moore J, Manubolu VS, Dahal S, Verghese D, Lakshmanan S, Hussein L, Crabtree T, Jonas R, Min JK, Earls JP, Budoff MJ. Plaque Progression Differences Between Apixaban and Rivaroxaban in Patients With Atrial Fibrillation Measured With Cardiac Computed Tomography and Plaque Quantification. Am J Ther. 2023 Jul-Aug 01;30(4):e313-e320. doi: 10.1097/MJT.0000000000001569. Epub 2022 Oct 18.

Study Officials

  • Jan G. Nijhuis, Prof dr MD PhD

    Maastricht University Medical Center

    STUDY CHAIR
  • Marijke JC Hendrix, MBA

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

April 2, 2010

Record last verified: 2010-04

Locations