A Swedish Trial of Birth on a Birthing Seat

NCT01164657 | Completed

• 1 other identifier: 2005/214
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

upright position; birth position; childbirth; instrumental deliveries; primiparous

Outcome Measures

Primary Outcomes (1)

• Number of women delivered instrumentally

  Information collected for each individual 2 hours after delivery. Material collected and analysed at completion of the study (May, 2006)

Secondary Outcomes (1)

• Administration of oxytocin for augmentation of labor

  Information collected for each individual, 2 hours after delivery. Material collected and summarised at completion of study (May, 2006).

Study Arms (2)

study group

EXPERIMENTAL

Randomized to give birth on a birthing seat

Device: "BirthRite"

control group

NO INTERVENTION

Randomized to birth in any other position except the birthing seat

Device: "BirthRite"

Interventions

"BirthRite" DEVICE

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

Also known as: "BirthRite" birthing seat

control group; study group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsingborgs Hospital: lead
• Stig and Ragna Gorthons foundation: collaborator

Study Sites (1)

Helsingborgs Hospital

Helsingborg, Skåne County, 25187, Sweden

Location

Study Officials

• Claes Lindoff, PhD, MD

  Helsingborgs Hospital

  STUDY DIRECTOR

• Linda J Kvist, PhD, RM

  Helsingborgs Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: July 19, 2010
• Study Start: November 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: July 19, 2010

Record last verified: 2009-08

Locations

SE (1)