Parturition Clinical Trial
Official title:
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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