The Swedish Birth Seat Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1002 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Birth seat group

Randomized to birth on a midwife designed birth seat

Group Type EXPERIMENTAL

BirthRite birthing seat

Intervention Type DEVICE

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.

Non-birth seat group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BirthRite birthing seat

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.

Intervention Type DEVICE

Other Intervention Names

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BirthRite® birthing seat

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes