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A Swedish Trial of Birth on a Birthing Seat

NCT01164657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2010-07-19

No results posted yet for this study

Summary

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).

Conditions

  • Parturition

Interventions

DEVICE

"BirthRite"

Randomization takes place on admission to delivery unit, study group participants seated on the birthing seat when cervix is fully dilated.

Sponsors & Collaborators

  • Stig and Ragna Gorthons foundation

    collaborator UNKNOWN

  • Helsingborgs Hospital

    lead OTHER

Principal Investigators

  • Claes Lindoff, PhD, MD · Helsingborgs Hospital

  • Linda J Kvist, PhD, RM · Helsingborgs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164657 on ClinicalTrials.gov