Low Risk Birth; Births With Low Risk FactorNCT00857129
Can Differentiated Birth Care Improve the Service?
A study testing Normal Unit and Special birth unit in people with Low Risk Birth; Births With Low Risk Factor, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Risk Birth; Births With Low Risk Factor
- What is being tested?
- Normal Unit and Special birth unit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,111 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Dec 2013
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy mother, normal pregnancy, no prior operations on the uterus, no prior birth complications, no condition with negative effect on pregnancy or birth,one fetus in head position, spontaneously going into birth between week 36,1 and 41,6 of pregnancy,normal cardiotocograph test BMI of 32 or less, smoking no more than 10 cigarettes per day, wants to participate in the study and signs the consent form.
Who cannot join
- Any condition that has negative effect on the pregnancy or the birth, more than one fetus, all other positions than head position, induction of labor,pre term or post term birth, BMI of more than 32, smoking more than 10 cigarettes per day, does not want to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differentiated Birth Service- an Improvement?
Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital.
Read the detailed description
The study will include approximately 1000 normal births in a county hospital. The mothers are randomly assigned to one of three different maternal wards; one run by midwives, one normally equipped according to national standards for a county hospital and one prepared for complicated births. Endpoints are number of operative births and complications.
- Being tested
- Normal Unit, Special birth unit
- Keywords
- "normal birth", "birth outcome", "low risk birth", "low risk units", If type of birth care unit have effect on birth outcome, Apgar score, breast feeding frequency, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal UnitProcedure or surgery
Also called Normal Unit, low-risk women
low-risk patients randomised to Normal Unit
Special birth unitProcedure or surgery
Also called Standard care unit: The Special Unit.
Low-risk women are randomised to the Special birth unit. Organised to take care of women with extended need for surveillance before, under and after birth.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Low risk women with expected normal birth are being Randomized to The Midwife-led Unit, with low amount of intervention, No epidural is offered, no medical augmentation available, unless for the active phase of the second stage. If extended surveillance is necessary or if the birth no longer is considered to be normal and needs to be taken over by a doctor, the woman will be transferred to either the Normal Unit or the Special Unit |
| 2 | Experimental | Low-risk women are randomised to this Low-risk maternal unit, The Normal Unit.The unit is organised for low-risk women with expected normal birth. The unit has access to extended surveillance, epidural and operative vaginal deliveries. If extended surveillance is necessary for a woman randomised to this unit, she does not have to be transferred to a higher level of care. Instrumental vaginal deliveries can be carried out at this unit. Receives: Procedure: Normal Unit |
| 3 | Experimental | Women with expected normal births are being randomised to this Special birth unit designed to take care of women before, under and after birth. The Special Unit cares for women with extended need for surveillance, but does also handle low-risk women. Receives: Procedure: Special birth unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of operative deliveries
Measured: one week
Secondary outcomes (1)
number of registered complications
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startSep 2006
- Primary completionMar 2010
- Study completionDec 2013
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 Low Risk Birth; Births With Low Risk FactorStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Principal investigator, Stine Bernitz, Ostfold Hospital Trust
- Investigators
- Pal Oian, PhD, Principal investigator, University of Tromso, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857129
- Sponsor's protocol ID
- 3100
- Status last verified
- Oct 2014
- First submitted
- 5 Mar 2009
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernitz S, Oian P, Sandvik L, Blix E. Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women. BMC Pregnancy Childbirth. 2016 Jun 18;16(1):143. doi: 10.1186/s12884-016-0932-x.
PubMed 27316335
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiated Birth Service- an Improvement?
- ClinicalTrials.gov ID
- NCT00857129
- Acronym / sponsor ID
- 3100
- Keywords
- "normal birth", "birth outcome", "low risk birth", "low risk units", If type of birth care unit have effect on birth outcome, Apgar score, breast feeding frequency, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Sep 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Mar 2009 (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.
Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital.
Detailed description
The study will include approximately 1000 normal births in a county hospital. The mothers are randomly assigned to one of three different maternal wards; one run by midwives, one normally equipped according to national standards for a county hospital and one prepared for complicated births. Endpoints are number of operative births and complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Low risk women with expected normal birth are being Randomized to The Midwife-led Unit, with low amount of intervention, No epidural is offered, no medical augmentation available, unless for the active phase of the second stage. If extended surveillance is necessary or if the birth no longer is considered to be normal and needs to be taken over by a doctor, the woman will be transferred to either the Normal Unit or the Special Unit |
| 2 | Experimental | Procedure: Normal UnitLow-risk women are randomised to this Low-risk maternal unit, The Normal Unit.The unit is organised for low-risk women with expected normal birth. The unit has access to extended surveillance, epidural and operative vaginal deliveries. If extended surveillance is necessary for a woman randomised to this unit, she does not have to be transferred to a higher level of care. Instrumental vaginal deliveries can be carried out at this unit. |
| 3 | Experimental | Procedure: Special birth unitWomen with expected normal births are being randomised to this Special birth unit designed to take care of women before, under and after birth. The Special Unit cares for women with extended need for surveillance, but does also handle low-risk women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy mother, normal pregnancy, no prior operations on the uterus, no prior birth complications, no condition with negative effect on pregnancy or birth,one fetus in head position, spontaneously going into birth between week 36,1 and 41,6 of pregnancy,normal cardiotocograph test BMI of 32 or less, smoking no more than 10 cigarettes per day, wants to participate in the study and signs the consent form.
Key exclusion criteria (1 listed)
- Any condition that has negative effect on the pregnancy or the birth, more than one fetus, all other positions than head position, induction of labor,pre term or post term birth, BMI of more than 32, smoking more than 10 cigarettes per day, does not want to participate.
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 |
|---|---|---|
| Normal UnitAlso: Normal Unit, low-risk womenlow-risk patients randomised to Normal Unit | Procedure or surgery | 2 |
| Special birth unitAlso: Standard care unit: The Special Unit.Low-risk women are randomised to the Special birth unit. Organised to take care of women with extended need for surveillance before, under and after birth. | Procedure or surgery | 3 |
Primary outcome
Number of operative deliveries
Time frame: one week
1 secondary outcome
number of registered complications
Time frame: one week
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 20 Oct 2014.
- Derived from this study: PubMed 27316335Bernitz S, Oian P, Sandvik L, Blix E. Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women. BMC Pregnancy Childbirth. 2016 Jun 18;16(1):143. doi: 10.1186/s12884-016-0932-x.
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.
Pal Oian, PhD principal investigator
University of Tromso, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Unit and Special birth unit in people with Low Risk Birth; Births With Low Risk Factor, run by Ostfold Hospital Trust at 1 site in Norway.
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 1 inclusion and 1 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 20 Oct 2014. 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 Norway. 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?
Number of operative deliveries (time frame: one week). 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 NCT00857129, 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 20 Oct 2014.