The Swedish Birth Seat Trial
|ClinicalTrials.gov Identifier: NCT01182038|
Recruitment Status : Completed
First Posted : August 16, 2010
Last Update Posted : August 16, 2010
|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.
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|