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

August 10, 2010
August 13, 2010
November 2007
July 2009   (final data collection date for primary outcome measure)
Instrumental vaginal births [ Time Frame: Recorded within 6 hours postpartum ] [ Designated as safety issue: No ]
Instrumental births include vacuum extraction and forceps delivery.
Same as current
Complete list of historical versions of study NCT01182038 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Swedish Birth Seat Trial
The Swedish Birth Seat Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Instrumental Vaginal Births
  • Oxytocin Augmentation for Labor
  • Maternal Blood Loss
  • Perineal Outcomes
  • Fetal Outcomes
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
  • Experimental: Birth seat group
    Randomized to birth on a midwife designed birth seat
    Intervention: Device: BirthRite birthing seat
  • No Intervention: Non-birth seat group
    Randomized to birth in any other position except on the midwife designed birth seat.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1002
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01182038
2009/739
Yes
Li Thies-Lagergren, MMid, Reg. Midwife, Reg. Nurse, Doctoral student, The Karolinska Institute, Stockholm and Helsingborgs Hospital, Sweden.
Helsingborgs Hospital
The Stig & Ragna Gorthon Foundation, Helsingborg
Study Director: Ingegerd Hildingsson, PhD Karolinska Institutet
Study Chair: Linda J Kvist, PhD Helsingborg Hospital, Sweden
Helsingborgs Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP