The Swedish Birth Seat Trial
This study has been completed.
Sponsor:
Helsingborgs Hospital
Collaborator:
The Stig & Ragna Gorthon Foundation, Helsingborg
Information provided by:
Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01182038
First received: August 10, 2010
Last updated: August 13, 2010
Last verified: August 2010
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Purpose
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.
Condition | Intervention |
---|---|
Instrumental Vaginal Births Oxytocin Augmentation for Labor Maternal Blood Loss Perineal Outcomes Fetal Outcomes |
Device: BirthRite birthing seat |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
Official Title: | The Swedish Birth Seat Trial |
Resource links provided by NLM:
Further study details as provided by Helsingborgs Hospital:
Primary Outcome Measures:
- Instrumental vaginal births [ Time Frame: Recorded within 6 hours postpartum ] [ Designated as safety issue: No ]Instrumental births include vacuum extraction and forceps delivery.
Secondary Outcome Measures:
- Administration of oxytocin for augmentation of labor [ Time Frame: During labor and birth up to 36 hours postpartum ] [ Designated as safety issue: No ]
- Postpartum blood loss [ Time Frame: Up to 24 hours after birth ] [ Designated as safety issue: No ]Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.
- Perineal outcomes [ Time Frame: Up to 36 hours after birth ] [ Designated as safety issue: No ]Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.
- Fetal outcomes [ Time Frame: Up to 36 hours after birth ] [ Designated as safety issue: No ]Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.
Enrollment: | 1002 |
Study Start Date: | November 2007 |
Study Completion Date: | July 2009 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Birth seat group
Randomized to birth on a midwife designed birth seat
|
Device: 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.
Other Name: BirthRite® birthing seat
|
No Intervention: Non-birth seat group
Randomized to birth in any other position except on the midwife designed birth seat.
|
Eligibility
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182038
Locations
Sweden | |
Helsingborgs Hospital | |
Helsingborg, Skane, Sweden, 25187 |
Sponsors and Collaborators
Helsingborgs Hospital
The Stig & Ragna Gorthon Foundation, Helsingborg
Investigators
Study Director: | Ingegerd Hildingsson, PhD | Karolinska Institutet |
Study Chair: | Linda J Kvist, PhD | Helsingborg Hospital, Sweden |
More Information
No publications provided by Helsingborgs Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Keywords provided by Helsingborgs Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided by Helsingborgs Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Li Thies-Lagergren, MMid, Reg. Midwife, Reg. Nurse, Doctoral student, The Karolinska Institute, Stockholm and Helsingborgs Hospital, Sweden. |
ClinicalTrials.gov Identifier: | NCT01182038 History of Changes |
Other Study ID Numbers: | 2009/739 |
Study First Received: | August 10, 2010 |
Last Updated: | August 13, 2010 |
Health Authority: | Sweden: Regional Ethical Review Board Sweden: Swedish National Council on Medical Ethics |
Keywords provided by Helsingborgs Hospital:
birth seat childbirth instrumental delivery upright position |
Additional relevant MeSH terms:
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on October 17, 2012