The Swedish Birth Seat Trial

Study Overview
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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.

Official Title
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The Swedish Birth Seat Trial

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

Intervention / Treatment
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* Device: BirthRite birthing seat


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Birth seat group<br>Randomized to birth on a midwife designed birth seat | Device: BirthRite birthing seat<br>* 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.<br>* Other names: BirthRite® birthing seat;|
| No Intervention: Non-birth seat group<br>Randomized to birth in any other position except on the midwife designed birth seat. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental vaginal births | Instrumental births include vacuum extraction and forceps delivery. | Recorded within 6 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administration of oxytocin for augmentation of labor |  | During labor and birth up to 36 hours postpartum | 
| Postpartum blood loss | Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered. | Up to 24 hours after birth | 
| Perineal outcomes | Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema. | Up to 36 hours after birth | 
| Fetal outcomes | Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU. | Up to 36 hours after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth seat, childbirth, instrumental delivery, upright position