The Swedish Birth Seat Trial

August 13, 2010 updated by: Helsingborgs Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1002

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skane
      • Helsingborg, Skane, Sweden, 25187
        • Helsingborgs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • BirthRite® birthing seat
No Intervention: Non-birth seat group
Randomized to birth in any other position except on the midwife designed birth seat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental vaginal births
Time Frame: Recorded within 6 hours postpartum
Instrumental births include vacuum extraction and forceps delivery.
Recorded within 6 hours postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration of oxytocin for augmentation of labor
Time Frame: During labor and birth up to 36 hours postpartum
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.
Up to 24 hours after birth
Perineal outcomes
Time Frame: Up to 36 hours after birth
Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.
Up to 36 hours after birth
Fetal outcomes
Time Frame: Up to 36 hours after birth
Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.
Up to 36 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsingborgs Hospital

Collaborators

The Stig & Ragna Gorthon Foundation, Helsingborg

Investigators

  • Study Director: Ingegerd Hildingsson, PhD, Karolinska Institutet
  • Study Chair: Linda J Kvist, PhD, Helsingborg Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 13, 2010

First Posted (Estimate)

August 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 16, 2010

Last Update Submitted That Met QC Criteria

August 13, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/739

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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