A Swedish Trial of Birth on a Birthing Seat

July 16, 2010 updated by: Helsingborgs Hospital

A Swedish Randomized Controlled Trial of Birth on a Birthing Seat

Background:

The World Health Organization (WHO) advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position she finds most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery.

Objective:

The primary objective was to test the hypothesis that birthing on the "BirthRite" ® seat will result in a reduction in the number of primiparous women delivered instrumentally.

Method:

A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was decided to subject the study to a feasibility test by conducting a pilot-study in which 68 women were randomised to give birth on the birthing seat or to give birth in any other position but on the "BirthRite" ® seat. Randomization to birth on the birthing seat or in any other position took place when the participant's cervix was fully dilated. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin for augmentation of labour, length of the second stage of labour, perineal trauma, perineal oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the Neonatal Intensive Care Unit(NICU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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:

  • The pilot study included primiparous women who understood the Swedish language sufficiently well to receive information and give informed consent or refusal for participation.
  • Pregnancy must have been normal, with a singleton fetus in cephalic presentation and the onset of labour occurring between gestation weeks 37 + 0 and 41 + 6.
  • Women having diet treated pregnancy diabetes were also included.
  • Obstetric primiparous women with former caesarean section were included as well as those induced because of premature rupture of membranes (PROM).

Exclusion Criteria:

  • Multiparous women were excluded from the pilot study.
  • Primiparous women were excluded in cases of birth before week 36 + 6, breech presentation, maternal BMI over 30, multiple pregnancy or infectious disease.
  • Primiparous women with pre-eclampsia or other conditions that require medical care were not eligible for the pilot study.

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: study group
Randomized to give birth on a birthing seat
Device: "BirthRite"
Randomization takes place on admission to delivery unit, study group participants seated on the birthing seat when cervix is fully dilated.
Other Names:
  • "BirthRite" birthing seat
No Intervention: control group
Randomized to birth in any other position except the birthing seat
Device: "BirthRite"
Randomization takes place on admission to delivery unit, study group participants seated on the birthing seat when cervix is fully dilated.
Other Names:
  • "BirthRite" birthing seat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of women delivered instrumentally
Time Frame: Information collected for each individual 2 hours after delivery. Material collected and analysed at completion of the study (May, 2006)
Information collected for each individual 2 hours after delivery. Material collected and analysed at completion of the study (May, 2006)

Secondary Outcome Measures

Outcome Measure
Time Frame
Administration of oxytocin for augmentation of labor
Time Frame: Information collected for each individual, 2 hours after delivery. Material collected and summarised at completion of study (May, 2006).
Information collected for each individual, 2 hours after delivery. Material collected and summarised at completion of study (May, 2006).

Collaborators and Investigators

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

Sponsor

Helsingborgs Hospital

Collaborators

Stig and Ragna Gorthons foundation

Investigators

  • Study Director: Claes Lindoff, PhD, MD, Helsingborgs Hospital
  • Study Chair: Linda J Kvist, PhD, RM, Helsingborgs Hospital

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, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 19, 2010

Study Record Updates

Last Update Posted (Estimate)

July 19, 2010

Last Update Submitted That Met QC Criteria

July 16, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2005/214

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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