The Swedish Birth Seat Trial

Maternal Blood Loss Clinical Trial

Official title:

The Swedish Birth Seat Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182038
• Other study ID #: 2009/739
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: August 13, 2010
• Start date: November 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2010
• Source: Helsingborgs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Sweden	Helsingborgs Hospital	Helsingborg	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Helsingborgs Hospital	The Stig & Ragna Gorthon Foundation, Helsingborg

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instrumental vaginal births	Instrumental births include vacuum extraction and forceps delivery.	Recorded within 6 hours postpartum	No
Secondary	Administration of oxytocin for augmentation of labor		During labor and birth up to 36 hours postpartum	No
Secondary	Postpartum blood loss	Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.	Up to 24 hours after birth	No
Secondary	Perineal outcomes	Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.	Up to 36 hours after birth	No
Secondary	Fetal outcomes	Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.	Up to 36 hours after birth	No