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The Swedish Birth Seat Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182038
First Posted: August 16, 2010
Last Update Posted: August 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Stig & Ragna Gorthon Foundation, Helsingborg
Information provided by:
Helsingborgs Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
  • Postpartum blood loss [ Time Frame: Up to 24 hours after birth ]
    Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.

  • Perineal outcomes [ Time Frame: Up to 36 hours after birth ]
    Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.

  • Fetal outcomes [ Time Frame: Up to 36 hours after birth ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 10, 2010
First Posted: August 16, 2010
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by Helsingborgs Hospital:
birth seat
childbirth
instrumental delivery
upright position