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Be Part of Research - Trial Details - Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women
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Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

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Open to: FEMALE

Age: 18.0 - 40.0

Cambridge Cambridge

Medical Conditions

Postpartum Hemorrhage
Hemorrhage

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The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study is being conducted to further assess safety and tolerability of inhaled oxytocin, and to characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active management of the third stage of labour (after the baby is born). Group 2 will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the safety and tolerability of IH and IV oxytocin.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2016 Mar 2019

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).

Intervention Arm Group : Group 1 -IH oxytocin;Group 2 (IH and IV oxytocin);

Intervention Type : DRUG
Intervention Description : Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration

Intervention Arm Group : Group 1 -IM oxytocin;

Intervention Type : DRUG
Intervention Description : Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.

Intervention Arm Group : Group 2 (IH and IV oxytocin);

Intervention Type : DEVICE
Intervention Description : ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin

Intervention Arm Group : Group 1 -IH oxytocin;Group 2 (IH and IV oxytocin);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • GSK Investigational Site
    Cambridge
    Cambridgeshire
    CB2 2GG
  • GSK Investigational Site
    Cambridge
    CB2 2GG


The study is sponsored by GlaxoSmithKline and is in collaboration with InVentiv Clinique; Monash University.



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Read full details for Trial ID: NCT02999100
Last updated 10 March 2020

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