The Swedish Birth Seat Trial

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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

ClinicalTrials.gov processed this record on October 16, 2014