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Completed

NCT Number: NCT01164657

A Swedish 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).

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Helsingborgs Hospital

Helsingborg, Skåne County, 25187, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"BirthRite"

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Helsingborgs Hospital

Other

Collaborators

  • Stig and Ragna Gorthons foundation

Registry information

Official study title

A Swedish Randomized Controlled Trial of Birth on a Birthing Seat

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 19, 2010
Registry last updated
Jul 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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