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Clinical Trials/NCT01182038
NCT01182038CompletedNot Applicable

The Swedish Birth Seat Trial

Helsingborgs Hospital2 sites in 1 country1,002 target enrollmentStarted: November 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,002
Locations
2
Primary Endpoint
Instrumental vaginal births
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Instrumental vaginal births

Time Frame: Recorded within 6 hours postpartum

Instrumental births include vacuum extraction and forceps delivery.

Secondary Outcomes

  • Administration of oxytocin for augmentation of labor(During labor and birth up to 36 hours postpartum)
  • Postpartum blood loss(Up to 24 hours after birth)
  • Perineal outcomes(Up to 36 hours after birth)
  • Fetal outcomes(Up to 36 hours after birth)

Investigators

Sponsor
Helsingborgs Hospital
Sponsor Class
Other

Study Sites (2)

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The Swedish Birth Seat Trial | Clinical Trial