The Swedish Birth Seat Trial
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|ClinicalTrials.gov Identifier: NCT01182038|
Recruitment Status : Completed
First Posted : August 16, 2010
Last Update Posted : August 16, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Instrumental Vaginal Births Oxytocin Augmentation for Labor Maternal Blood Loss Perineal Outcomes Fetal Outcomes||Device: BirthRite birthing seat||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1002 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Swedish Birth Seat Trial|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Experimental: Birth seat group
Randomized to birth on a midwife designed birth seat
Device: 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.
Other Name: BirthRite® birthing seat
No Intervention: Non-birth seat group
Randomized to birth in any other position except on the midwife designed birth seat.
- Instrumental vaginal births [ Time Frame: Recorded within 6 hours postpartum ]Instrumental births include vacuum extraction and forceps delivery.
- Administration of oxytocin for augmentation of labor [ Time Frame: During labor and birth up to 36 hours postpartum ]
- Postpartum blood loss [ Time Frame: Up to 24 hours after birth ]Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.
- Perineal outcomes [ Time Frame: Up to 36 hours after birth ]Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.
- Fetal outcomes [ Time Frame: Up to 36 hours after birth ]Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182038
|Helsingborg, Skane, Sweden, 25187|
|Study Director:||Ingegerd Hildingsson, PhD||Karolinska Institutet|
|Study Chair:||Linda J Kvist, PhD||Helsingborg Hospital, Sweden|
|Responsible Party:||Li Thies-Lagergren, MMid, Reg. Midwife, Reg. Nurse, Doctoral student, The Karolinska Institute, Stockholm and Helsingborgs Hospital, Sweden.|
|Other Study ID Numbers:||
|First Posted:||August 16, 2010 Key Record Dates|
|Last Update Posted:||August 16, 2010|
|Last Verified:||August 2010|