ParturitionNCT01164657
A Swedish Trial of Birth on a Birthing Seat
A study testing "BirthRite" in people with Parturition, run by Helsingborgs Hospital at 1 site in Sweden.
Trial summary
Background: The World Health Organization (WHO) advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position she finds most comfortable. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturition
- What is being tested?
- "BirthRite"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2005to May 2006
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The pilot study included primiparous women who understood the Swedish language sufficiently well to receive information and give informed consent or refusal for participation.
- Pregnancy must have been normal, with a singleton fetus in cephalic presentation and the onset of labour occurring between gestation weeks 37 + 0 and 41 + 6.
- Women having diet treated pregnancy diabetes were also included.
- Obstetric primiparous women with former caesarean section were included as well as those induced because of premature rupture of membranes (PROM).
Who cannot join
- Multiparous women were excluded from the pilot study.
- Primiparous women were excluded in cases of birth before week 36 + 6, breech presentation, maternal BMI over 30, multiple pregnancy or infectious disease.
- Primiparous women with pre-eclampsia or other conditions that require medical care were not eligible for the pilot study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Swedish Randomized Controlled Trial of Birth on a Birthing Seat
Background:
The World Health Organization (WHO) advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position she finds most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery.
Read more
Objective:
The primary objective was to test the hypothesis that birthing on the "BirthRite" ® seat will result in a reduction in the number of primiparous women delivered instrumentally.
Method:
A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was decided to subject the study to a feasibility test by conducting a pilot-study in which 68 women were randomised to give birth on the birthing seat or to give birth in any other position but on the "BirthRite" ® seat. Randomization to birth on the birthing seat or in any other position took place when the participant's cervix was fully dilated. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin for augmentation of labour, length of the second stage of labour, perineal trauma, perineal oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the Neonatal Intensive Care Unit(NICU).
- Conditions
- Parturition
- Being tested
- "BirthRite"
- Keywords
- upright position, birth position, childbirth, instrumental deliveries, primiparous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"BirthRite"Device
Also called "BirthRite" birthing seat
Randomization takes place on admission to delivery unit, study group participants seated on the birthing seat when cervix is fully dilated.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Randomized to give birth on a birthing seat Receives: Device: "BirthRite" |
| control group | No intervention | Randomized to birth in any other position except the birthing seat Receives: Device: "BirthRite" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women delivered instrumentally
Measured: Information collected for each individual 2 hours after delivery. Material collected and analysed at completion of the study (May, 2006)
Secondary outcomes (1)
Administration of oxytocin for augmentation of labor
Measured: Information collected for each individual, 2 hours after delivery. Material collected and summarised at completion of study (May, 2006).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startNov 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsingborgs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stig and Ragna Gorthons foundation
- Investigators
- Claes Lindoff, PhD, MD, Study director, Helsingborgs HospitalLinda J Kvist, PhD, RM, Study chair, Helsingborgs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164657
- Sponsor's protocol ID
- 2005/214
- Status last verified
- Aug 2009
- First submitted
- 4 Mar 2009
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Swedish Randomized Controlled Trial of Birth on a Birthing Seat
- ClinicalTrials.gov ID
- NCT01164657
- Acronym / sponsor ID
- 2005/214
- Conditions
- Parturition
- Keywords
- upright position, birth position, childbirth, instrumental deliveries, primiparous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Helsingborgs HospitalUniversity, hospital or other
- Collaborators
- Stig and Ragna Gorthons foundation
- Study start
- Nov 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 19 Jul 2010 (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.
Background:
The World Health Organization (WHO) advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position she finds most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery.
Objective:
The primary objective was to test the hypothesis that birthing on the "BirthRite" ® seat will result in a reduction in the number of primiparous women delivered instrumentally.
Method:
A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was decided to subject the study to a feasibility test by conducting a pilot-study in which 68 women were randomised to give birth on the birthing seat or to give birth in any other position but on the "BirthRite" ® seat. Randomization to birth on the birthing seat or in any other position took place when the participant's cervix was fully dilated. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin for augmentation of labour, length of the second stage of labour, perineal trauma, perineal oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the Neonatal Intensive Care Unit(NICU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: "BirthRite"Randomized to give birth on a birthing seat |
| control group | No intervention | Device: "BirthRite"Randomized to birth in any other position except the birthing seat |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The pilot study included primiparous women who understood the Swedish language sufficiently well to receive information and give informed consent or refusal for participation.
- Pregnancy must have been normal, with a singleton fetus in cephalic presentation and the onset of labour occurring between gestation weeks 37 + 0 and 41 + 6.
- Women having diet treated pregnancy diabetes were also included.
- Obstetric primiparous women with former caesarean section were included as well as those induced because of premature rupture of membranes (PROM).
Key exclusion criteria (3 listed)
- Multiparous women were excluded from the pilot study.
- Primiparous women were excluded in cases of birth before week 36 + 6, breech presentation, maternal BMI over 30, multiple pregnancy or infectious disease.
- Primiparous women with pre-eclampsia or other conditions that require medical care were not eligible for the pilot study.
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 |
|---|---|---|
| "BirthRite"Also: "BirthRite" birthing seatRandomization takes place on admission to delivery unit, study group participants seated on the birthing seat when cervix is fully dilated. | Device | control group, study group |
Primary outcome
Number of women delivered instrumentally
Time frame: Information collected for each individual 2 hours after delivery. Material collected and analysed at completion of the study (May, 2006)
1 secondary outcome
Administration of oxytocin for augmentation of labor
Time frame: Information collected for each individual, 2 hours after delivery. Material collected and summarised at completion of study (May, 2006).
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 19 Jul 2010.
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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.
Claes Lindoff, PhD, MD study director
Helsingborgs Hospital
Linda J Kvist, PhD, RM study chair
Helsingborgs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "BirthRite" in people with Parturition, run by Helsingborgs Hospital at 1 site in Sweden.
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 3 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 19 Jul 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 Sweden. 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 women delivered instrumentally (time frame: Information collected for each individual 2 hours after delivery. Material collected and analysed at completion of the study (May, 2006)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2010.