PregnancyNCT00237601
Home or Home-like Hospital Birth
An observational study of Pregnancy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- obstetric care
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home or Home-like Hospital Birth for Low-risk Nulliparae: Does it Matter?
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.
Read more
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.
- Conditions
- Pregnancy
- Being tested
- obstetric care
- Keywords
- Home birth, Hospital birth, Midwifery, Effectivity, Efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obstetric careOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with the intention to give birth at home Receives: Other: obstetric care | |
| 2 | Women with the intention to give birth in a short-stay hospital setting Receives: Other: obstetric care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- School for Midwifery Maastricht
- Investigators
- Jan G. Nijhuis, Prof dr MD PhD, Study chair, Maastricht University Medical CenterMarijke JC Hendrix, MBA, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237601
- Sponsor's protocol ID
- PF 198
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36731003
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home or Home-like Hospital Birth for Low-risk Nulliparae: Does it Matter?
- ClinicalTrials.gov ID
- NCT00237601
- Acronym / sponsor ID
- PF 198
- Conditions
- Pregnancy
- Keywords
- Home birth, Hospital birth, Midwifery, Effectivity, Efficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- School for Midwifery Maastricht
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: obstetric careWomen with the intention to give birth at home |
| 2 | – | Other: obstetric careWomen with the intention to give birth in a short-stay hospital setting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obstetric care | Other | 1, 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
- Derived from this study: PubMed 36731003Aldana-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan G. Nijhuis, Prof dr MD PhD study chair
Maastricht University Medical Center
Marijke JC Hendrix, MBA principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2010.