Instrumental Vaginal BirthsNCT01182038
The Swedish Birth Seat Trial
A study testing BirthRite birthing seat in people with Instrumental Vaginal Births and Oxytocin Augmentation for Labor, run by Helsingborgs Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether birth on a birthing seat will effect numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of artificial oxytocin for labour augmentation and fetal outcomes. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Instrumental Vaginal Births, Oxytocin Augmentation for Labor, Maternal Blood Loss
- What is being tested?
- BirthRite birthing seat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Jul 2009
- 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
- nulliparous women who understood the Swedish language sufficiently well to receive information and give informed consent
- a normal pregnancy,singleton fetus in cephalic presentation
- spontaneous onset of labor occurring between gestational weeks 37 + 0 and 41 + 6
- Body Mass Index less (BMI) than thirty
- gestational diabetes not requiring medical treatment
- women who were planning a vaginal birth after a caesarean section (VBAC)
- women induced because of spontaneous rupture of membranes with no spontaneous contractions for longer than twenty-four hours
Who cannot join
- multiparous women
- birth before gestational week 37
- breech presentation
- maternal BMI more than 30
- multiple pregnancy
- infectious disease
- pre-eclampsia or other conditions requiring medical care
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether birth on a birthing seat will effect numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of artificial oxytocin for labour augmentation and fetal outcomes.
- Conditions
- Instrumental Vaginal Births, Oxytocin Augmentation for Labor, Maternal Blood Loss, Perineal Outcomes, Fetal Outcomes
- Being tested
- BirthRite birthing seat
- Keywords
- birth seat, childbirth, instrumental delivery, upright position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirthRite birthing seatDevice
Also called BirthRite® birthing seat
Randomization takes place on admission to the labor ward when the participants are in active labor.Participants in this arm were to sit on the seat for 20 minute periods.After these 20 minutes, the participant should stand and mobilize during two to three contractions, before resuming the birth seat position. If progress of the descent of the fetal head was obvious the participant was not asked to mobilize.
| Study group | Role | What they receive |
|---|---|---|
| Birth seat group | Experimental | Randomized to birth on a midwife designed birth seat Receives: Device: BirthRite birthing seat |
| Non-birth seat group | No intervention | Randomized to birth in any other position except on the midwife designed birth seat. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental vaginal births
Instrumental births include vacuum extraction and forceps delivery.
Measured: Recorded within 6 hours postpartum
Secondary outcomes (4)
Administration of oxytocin for augmentation of labor
Measured: During labor and birth up to 36 hours postpartum
Postpartum blood loss
Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.
Measured: Up to 24 hours after birth
Perineal outcomes
Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.
Measured: Up to 36 hours after birth
Fetal outcomes
Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.
Measured: Up to 36 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Instrumental Vaginal BirthsStudies 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
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsingborgs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Stig & Ragna Gorthon Foundation, Helsingborg
- Investigators
- Ingegerd Hildingsson, PhD, Study director, Karolinska InstitutetLinda J Kvist, PhD, Study chair, Helsingborg Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182038
- Sponsor's protocol ID
- 2009/739
- Status last verified
- Aug 2010
- First submitted
- 10 Aug 2010
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. Striving for scientific stringency: a re-analysis of a randomised controlled trial considering first-time mothers' obstetric outcomes in relation to birth position. BMC Pregnancy Childbirth. 2012 Nov 22;12:135. doi: 10.1186/1471-2393-12-135.
PubMed 23173988Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial. BMC Pregnancy Childbirth. 2011 Mar 24;11:22. doi: 10.1186/1471-2393-11-22.
PubMed 21435238
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swedish Birth Seat Trial
- ClinicalTrials.gov ID
- NCT01182038
- Acronym / sponsor ID
- 2009/739
- Conditions
- Instrumental Vaginal Births, Oxytocin Augmentation for Labor, Maternal Blood Loss, Perineal Outcomes, Fetal Outcomes
- Keywords
- birth seat, childbirth, instrumental delivery, upright position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Helsingborgs HospitalUniversity, hospital or other
- Collaborators
- The Stig & Ragna Gorthon Foundation, Helsingborg
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Aug 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.
The purpose of this study is to determine whether birth on a birthing seat will effect numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of artificial oxytocin for labour augmentation and fetal outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Birth seat group | Experimental | Device: BirthRite birthing seatRandomized to birth on a midwife designed birth seat |
| Non-birth seat group | No intervention | –Randomized to birth in any other position except on the midwife designed birth seat. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- nulliparous women who understood the Swedish language sufficiently well to receive information and give informed consent
- a normal pregnancy,singleton fetus in cephalic presentation
- spontaneous onset of labor occurring between gestational weeks 37 + 0 and 41 + 6
- Body Mass Index less (BMI) than thirty
- gestational diabetes not requiring medical treatment
Key exclusion criteria (7 listed)
- multiparous women
- birth before gestational week 37
- breech presentation
- maternal BMI more than 30
- multiple pregnancy
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 birthing seatAlso: BirthRite® birthing seatRandomization takes place on admission to the labor ward when the participants are in active labor.Participants in this arm were to sit on the seat for 20 minute periods.After these 20 minutes, the participant should stand and mobilize during two to three contractions, before resuming the birth seat position. If progress of the descent of the fetal head was obvious the participant was not asked to mobilize. | Device | Birth seat group |
Primary outcome
Instrumental vaginal births
Time frame: Recorded within 6 hours postpartum
Instrumental births include vacuum extraction and forceps delivery.
4 secondary outcomes
Administration of oxytocin for augmentation of labor
Time frame: During labor and birth up to 36 hours postpartum
Postpartum blood loss
Time frame: Up to 24 hours after birth
Perineal outcomes
Time frame: Up to 36 hours after birth
Fetal outcomes
Time frame: Up to 36 hours after birth
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 16 Aug 2010.
- Derived from this study: PubMed 23173988Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. Striving for scientific stringency: a re-analysis of a randomised controlled trial considering first-time mothers' obstetric outcomes in relation to birth position. BMC Pregnancy Childbirth. 2012 Nov 22;12:135. doi: 10.1186/1471-2393-12-135.
- Derived from this study: PubMed 21435238Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial. BMC Pregnancy Childbirth. 2011 Mar 24;11:22. doi: 10.1186/1471-2393-11-22.
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.
Ingegerd Hildingsson, PhD study director
Karolinska Institutet
Linda J Kvist, PhD study chair
Helsingborg Hospital, Sweden
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 birthing seat in people with Instrumental Vaginal Births and Oxytocin Augmentation for Labor, 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 7 inclusion and 7 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 16 Aug 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?
Instrumental vaginal births (time frame: Recorded within 6 hours postpartum). 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 NCT01182038, which also lists 2 linked publications.
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 16 Aug 2010.