NCT01182038

Brief Summary

The purpose of this study is to determine whether birth on a birthing seat will effect numbers of instrumentally assisted vaginal births, vaginal traumas, blood loss,use of artificial oxytocin for labour augmentation and fetal outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,002

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

1.7 years

First QC Date

August 10, 2010

Last Update Submit

August 13, 2010

Conditions

Instrumental Vaginal BirthsOxytocin Augmentation for LaborMaternal Blood LossPerineal OutcomesFetal Outcomes

Keywords

birth seatchildbirthinstrumental deliveryupright position

Outcome Measures

Primary Outcomes (1)

  • Instrumental vaginal births

    Instrumental births include vacuum extraction and forceps delivery.

    Recorded within 6 hours postpartum

Secondary Outcomes (4)

  • Administration of oxytocin for augmentation of labor

    During labor and birth up to 36 hours postpartum

  • Postpartum blood loss

    Up to 24 hours after birth

  • Perineal outcomes

    Up to 36 hours after birth

  • Fetal outcomes

    Up to 36 hours after birth

Study Arms (2)

Birth seat group

EXPERIMENTAL

Randomized to birth on a midwife designed birth seat

Device: BirthRite birthing seat

Non-birth seat group

NO INTERVENTION

Randomized to birth in any other position except on the midwife designed birth seat.

Interventions

BirthRite birthing seatDEVICE

Randomization takes place on admission to the labor ward when the participants are in active labor.Participants in this arm were to sit on the seat for 20 minute periods.After these 20 minutes, the participant should stand and mobilize during two to three contractions, before resuming the birth seat position. If progress of the descent of the fetal head was obvious the participant was not asked to mobilize.

Also known as: BirthRite® birthing seat
Birth seat group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • nulliparous women who understood the Swedish language sufficiently well to receive information and give informed consent
  • a normal pregnancy,singleton fetus in cephalic presentation
  • spontaneous onset of labor occurring between gestational weeks 37 + 0 and 41 + 6
  • Body Mass Index less (BMI) than thirty
  • gestational diabetes not requiring medical treatment
  • women who were planning a vaginal birth after a caesarean section (VBAC)
  • women induced because of spontaneous rupture of membranes with no spontaneous contractions for longer than twenty-four hours

You may not qualify if:

  • multiparous women
  • birth before gestational week 37
  • breech presentation
  • maternal BMI more than 30
  • multiple pregnancy
  • infectious disease
  • pre-eclampsia or other conditions requiring medical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsingborgs Hospital

Helsingborg, Skåne County, 25187, Sweden

Location

Related Publications (2)

  • Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. Striving for scientific stringency: a re-analysis of a randomised controlled trial considering first-time mothers' obstetric outcomes in relation to birth position. BMC Pregnancy Childbirth. 2012 Nov 22;12:135. doi: 10.1186/1471-2393-12-135.

    PMID: 23173988DERIVED

  • Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial. BMC Pregnancy Childbirth. 2011 Mar 24;11:22. doi: 10.1186/1471-2393-11-22.

    PMID: 21435238DERIVED

Study Officials

  • Ingegerd Hildingsson, PhD

    Karolinska Institutet

    STUDY DIRECTOR

  • Linda J Kvist, PhD

    Helsingborg Hospital, Sweden

    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

August 10, 2010

First Posted

August 16, 2010

Study Start

November 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations

SE(1)