Not Yet RecruitingPhase 2ACTRN12615001173583

The effect of immediate cessation of intravenous oxytocin post birth on postpartum haemorrhage in spontaneous vaginal delivery following induction of labour with oxytocin: a comparison of three regimes.

The effect of cessation of intravenous oxytocin in women who have had an induction of labour with intravenous oxytocin and a spontaneous vaginal delivery, on postpartum measured blood loss: a three armed randomised controlled trial


Sponsor

Curtin University School of Nursing Midwifery and Paramedicine

Enrollment

312 participants

Start Date

Jan 18, 2016

Study Type

Interventional

Conditions

Summary

Oxytocin is a hormone which stimulates the smooth muscle of the uterus, producing rhythmic contractions, towards the end of pregnancy, during labour and after delivery. Synthetic oxytocin is a drug which is given to women in a drip (intravenous infusion) to help start (induce) and continue labour. Synthetic oxytocin is used because it helps establish contractions in a pattern similar to that of normal labour. If a woman has a spontaneous vaginal birth, it is generally the midwife who decides when to stop the synthetic oxytocin infusion after the birth of the baby. However, if she has an assisted vaginal birth (such as a vacuum or forceps birth) or caesarean birth, it may be the obstetrician who decides when to stop the synthetic oxytocin infusion after the birth of the baby. We are investigating the best time for the midwife to stop the synthetic oxytocin infusion after a spontaneous vaginal birth. We want to investigate this topic as there is no current evidence to guide this clinical practice. The primary aim of this study is to determine the proportion of women who have a postpartum haemorrhage, when intravenous oxytocin is ceased at 15, 30 or 60 minutes following completion of the third stage of labour. We hypothesise women who have intrapartum, intravenous oxytocin ceased at 15, 30 or 60 minutes following completion of the third stage of labour will experience the same rates of postpartum haemorrhage. We estimate that a total of 312 participants will need to be recruited to adequately power this study


Eligibility

Sex: FemalesMin Age: 16 Yearss

Inclusion Criteria6

  • Women would be included in the study if they:
  • Are more than or equal to 16 years old.
  • Receive intrapartum oxytocin for induction of labour.
  • Have a singleton pregnancy.
  • Are more than or equal to 37 weeks gestation.
  • Have a spontaneous vaginal delivery.

Exclusion Criteria8

  • Women would be excluded from the study if they:
  • Are <16 years old.
  • Have a multiple pregnancy.
  • Are <37 weeks gestation.
  • Commence intravenous oxytocin as part of the postpartum haemorrhage regime.
  • Have an assisted vaginal delivery.
  • Have a caesarean section.
  • Have their intravenous oxytocin ceased before delivery.

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Interventions

Arm 1, Intravenous oxytocin ceased within 15 minutes of completion of the third stage of labour. Arm2,Intravenous oxytocin ceased 30 minutes after completion of the third stage of labour. Arm 3, Int

Arm 1, Intravenous oxytocin ceased within 15 minutes of completion of the third stage of labour. Arm2,Intravenous oxytocin ceased 30 minutes after completion of the third stage of labour. Arm 3, Intravenous oxytocin ceased 60 minutes after completion of the third stage of labour. Oxytocin is titrated up from 12 to 108 mls per hour until contractions are established therefore some women will need 60 mls to get into established labour and some women will need 108mls. For analysis women will be grouped into low medium and high groups for the maximum amount of oxytocin reached.


Locations(1)

King Edward Memorial Hospital - Subiaco

WA, Australia

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ACTRN12615001173583