NCT02063568

Brief Summary

The purpose of this study is to evaluate the differences in blood clotting seen in healthy patients given two different doses of oxytocin following cesarean delivery. The secondary objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and differences in blood loss with the two separate doses of oxytocin.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 16, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

February 12, 2014

Last Update Submit

December 14, 2015

Conditions

Coagulation Changes With Oxytocin

Outcome Measures

Primary Outcomes (1)

  • coagulation as assessed by ROTEM

    30 minutes after oxytocin infusion started

Secondary Outcomes (4)

  • cardiac output changes with oxytocin

    from start of surgery until 30 min after oxytocin infusion started

  • incidence of nausea and vomiting with oxytocin

    from start of surgery until 30 minutes after oxytocin started

  • estimated blood loss with different doses of oxytocin

    upon completion of surgery

  • changes in blood pressure with oxytocin

    from start of surgery until 30 minutes after oxytocin started

Study Arms (2)

Low dose oxytocin infusion

ACTIVE COMPARATOR

oxytocin will be administered as an intravenous infusion at a rate of 0.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes

Drug: Oxytocin

High dose oxytocin infusion

ACTIVE COMPARATOR

oxytocin will be administered as an intravenous infusion at a rate of 1.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes

Drug: Oxytocin

Interventions

OxytocinDRUG
High dose oxytocin infusionLow dose oxytocin infusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Age \> or = 18 yrs
  • Non-laboring women
  • cesarean delivery under spinal anesthesia with pfannenstiel incision
  • ASA I-III

You may not qualify if:

  • Height \<5'0"
  • Allergy to phenylephrine
  • Severe cardiac disease in pregnancy with marked functional limitations
  • Women receiving NSAIDS, aspirin or other anticoagulants
  • Subject enrollment in another study involving a study medication within 30 days of cesarean delivery
  • Other physical or psychiatric condition which may impair the ability to cooperate with study data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

  • Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2012 Dec;109(6):851-63. doi: 10.1093/bja/aes361. Epub 2012 Oct 16.

    PMID: 23075633BACKGROUND

  • George RB, McKeen D, Chaplin AC, McLeod L. Up-down determination of the ED(90) of oxytocin infusions for the prevention of postpartum uterine atony in parturients undergoing Cesarean delivery. Can J Anaesth. 2010 Jun;57(6):578-82. doi: 10.1007/s12630-010-9297-1. Epub 2010 Mar 18.

    PMID: 20238255BACKGROUND

  • Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Oxytocin pretreatment attenuates oxytocin-induced contractions in human myometrium in vitro. Anesthesiology. 2013 Sep;119(3):552-61. doi: 10.1097/ALN.0b013e318297d347.

    PMID: 23676375BACKGROUND

  • Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.

    PMID: 22227638BACKGROUND

  • Butwick A, Harter S. An in vitro investigation of the coagulation effects of exogenous oxytocin using thromboelastography in healthy parturients. Anesth Analg. 2011 Aug;113(2):323-6. doi: 10.1213/ANE.0b013e3182222a82. Epub 2011 Jun 3.

    PMID: 21642611BACKGROUND

  • Neuenschwander S, Pliska V. Effects of neurohypophyseal hormone analogues on blood clotting factor VIII and fibrinolytic activity in sheep. Eur J Pharmacol. 1997 Apr 4;323(2-3):205-13. doi: 10.1016/s0014-2999(97)00036-8.

    PMID: 9128840BACKGROUND

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 16, 2015

Record last verified: 2015-10

Locations

US(1)