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The Swedish Birth Seat Trial

Primary Purpose

Instrumental Vaginal Births, Oxytocin Augmentation for Labor, Maternal Blood Loss

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

BirthRite birthing seat

About this trial

This is an interventional supportive care trial for Instrumental Vaginal Births focused on measuring birth seat, childbirth, instrumental delivery, upright position

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Helsingborgs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Birth seat group

Non-birth seat group

Arm Description

Randomized to birth on a midwife designed birth seat

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

Outcomes

Primary Outcome Measures

Instrumental vaginal births

Instrumental births include vacuum extraction and forceps delivery.

Secondary Outcome Measures

Administration of oxytocin for augmentation of labor

Postpartum blood loss

Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.

Perineal outcomes

Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.

Fetal outcomes

Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.

Full Information

NCT ID

NCT01182038

First Posted

August 10, 2010

Last Updated

August 13, 2010

Sponsor

Helsingborgs Hospital

Collaborators

The Stig & Ragna Gorthon Foundation, Helsingborg

1. Study Identification

Unique Protocol Identification Number

NCT01182038

Brief Title

The Swedish Birth Seat Trial

Official Title

The Swedish Birth Seat Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Helsingborgs Hospital

Collaborators

The Stig & Ragna Gorthon Foundation, Helsingborg

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Instrumental Vaginal Births, Oxytocin Augmentation for Labor, Maternal Blood Loss, Perineal Outcomes, Fetal Outcomes

Keywords

birth seat, childbirth, instrumental delivery, upright position

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1002 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Birth seat group

Arm Type

Experimental

Arm Description

Randomized to birth on a midwife designed birth seat

Arm Title

Non-birth seat group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

BirthRite birthing seat

Other Intervention Name(s)

BirthRite® birthing seat

Intervention Description

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.

Primary Outcome Measure Information:

Title

Instrumental vaginal births

Description

Instrumental births include vacuum extraction and forceps delivery.

Time Frame

Recorded within 6 hours postpartum

Secondary Outcome Measure Information:

Title

Administration of oxytocin for augmentation of labor

Time Frame

During labor and birth up to 36 hours postpartum

Title

Postpartum blood loss

Description

Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.

Time Frame

Up to 24 hours after birth

Title

Perineal outcomes

Description

Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.

Time Frame

Up to 36 hours after birth

Title

Fetal outcomes

Description

Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.

Time Frame

Up to 36 hours after birth

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ingegerd Hildingsson, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Linda J Kvist, PhD

Organizational Affiliation

Helsingborg Hospital, Sweden

Official's Role

Study Chair

Facility Information:

Facility Name

Helsingborgs Hospital

City

Helsingborg

State/Province

Skane

ZIP/Postal Code

25187

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

23173988

Citation

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.

Results Reference

derived

PubMed Identifier

21435238

Citation

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.

Results Reference

derived

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The Swedish Birth Seat Trial

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