The Swedish Birth Seat Trial

N/ACompletedNCT01182038

Helsingborgs Hospital1,002 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

1,002

Conditions

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

Interventions

BirthRite birthing seatDEVICE

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Helsingborgs Hospital

Helsingborg, Skåne County, Sweden

Outcomes

Primary Outcomes

Instrumental vaginal births

Instrumental births include vacuum extraction and forceps delivery.

Time frame: Recorded within 6 hours postpartum

Secondary Outcomes

Administration of oxytocin for augmentation of labor

Time frame: During labor and birth up to 36 hours postpartum

Postpartum blood loss

Blood loss postpartum is weighed and measured and maternal hemoglobin levels are registered.

Time frame: Up to 24 hours after birth

Perineal outcomes

Perineal outcomes include vaginal and perineal traumas, episiotomies and perineal edema.

Time frame: Up to 36 hours after birth

Fetal outcomes

Fetal outcomes include Apgar scores, cord blood pH levels and admissions to the NICU.

Time frame: Up to 36 hours after birth

Data from ClinicalTrials.gov

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