The Swedish Birth Seat Trial

• ClinicalTrials.gov Identifier: NCT01182038
• Recruitment Status: Completed
• First Posted: August 16, 2010
• Last Update Posted: August 16, 2010
• Sponsor: Helsingborgs Hospital
• Collaborator: The Stig & Ragna Gorthon Foundation, Helsingborg
• Information provided by: Helsingborgs Hospital

Study Description

Brief 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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1002 participants
• Allocation: Randomized
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Instrumental vaginal births [ Time Frame: Recorded within 6 hours postpartum ]
   Instrumental births include vacuum extraction and forceps delivery.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Sweden

Helsingborgs Hospital

Helsingborg, Skane, Sweden, 25187

Sponsors and Collaborators

Helsingborgs Hospital

The Stig & Ragna Gorthon Foundation, Helsingborg

Investigators

• Study Director: Ingegerd Hildingsson, PhD; Karolinska Institutet
• Study Chair: Linda J Kvist, PhD; Helsingborg Hospital, Sweden

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. Striving for scientific stringency: a re-analysis of a randomised controlled trial considering first-time mothers' obstetric outcomes in relation to birth position. BMC Pregnancy Childbirth. 2012 Nov 22;12:135. doi: 10.1186/1471-2393-12-135.

Thies-Lagergren L, Kvist LJ, Christensson K, Hildingsson I. No reduction in instrumental vaginal births and no increased risk for adverse perineal outcome in nulliparous women giving birth on a birth seat: results of a Swedish randomized controlled trial. BMC Pregnancy Childbirth. 2011 Mar 24;11:22. doi: 10.1186/1471-2393-11-22.

• Responsible Party: Li Thies-Lagergren, MMid, Reg. Midwife, Reg. Nurse, Doctoral student, The Karolinska Institute, Stockholm and Helsingborgs Hospital, Sweden.
• ClinicalTrials.gov Identifier: NCT01182038
• Other Study ID Numbers: 2009/739
• First Posted: August 16, 2010
• Last Update Posted: August 16, 2010
• Last Verified: August 2010

Keywords provided by Helsingborgs Hospital:

birth seat; childbirth; instrumental delivery; upright position

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes