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Completed

NCT Number: NCT01182038

The Swedish Birth Seat Trial

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Helsingborgs Hospital

Helsingborg, Skåne County, 25187, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BirthRite birthing seat

Device

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 names: BirthRite® birthing seat

Primary outcomes

  1. Instrumental vaginal births

    Time frame: Recorded within 6 hours postpartum

    Instrumental births include vacuum extraction and forceps delivery.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Helsingborgs Hospital

Other

Collaborators

  • The Stig & Ragna Gorthon Foundation, Helsingborg

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 16, 2010
Registry last updated
Aug 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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