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A Swedish Trial of Birth on a Birthing Seat

This study has been completed.
Sponsor:
Collaborator:
Stig and Ragna Gorthons foundation
Information provided by:
Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01164657
First received: March 4, 2009
Last updated: July 16, 2010
Last verified: August 2009
  Purpose

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).


Condition Intervention
Parturition
Device: "BirthRite"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Swedish Randomized Controlled Trial of Birth on a Birthing Seat

Resource links provided by NLM:


Further study details as provided by Helsingborgs Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: November 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: "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 Name: "BirthRite" birthing seat

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164657

Locations
Sweden
Helsingborgs Hospital
Helsingborg, Skane, Sweden, 25187
Sponsors and Collaborators
Helsingborgs Hospital
Stig and Ragna Gorthons foundation
Investigators
Study Director: Claes Lindoff, PhD, MD Helsingborgs Hospital
Study Chair: Linda J Kvist, PhD, RM Helsingborgs Hospital
  More Information

No publications provided

Responsible Party: Li Thies-Lagergren, Reg. Midwife, Mmid, Helsingborgs Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01164657     History of Changes
Other Study ID Numbers: 2005/214
Study First Received: March 4, 2009
Last Updated: July 16, 2010
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Helsingborgs Hospital:
upright position
birth position
childbirth
instrumental deliveries
primiparous

ClinicalTrials.gov processed this record on November 20, 2014