TerminatedPhase 1

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

Stopped: Inability to reliably measure plasma oxytocin levels during third stage labour, regardless of administration method (intramuscular or inhaled).

Australia, United Kingdom31 participantsStarted 2016-11-23

Plain-language summary

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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All Groups: * Between 18 and 40 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, and laboratory tests as required per protocol. * Subject clinical chemistry and haematology values within an acceptable range for the population recruited and not of abnormal clinical significance. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor (if required) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Adequate peripheral venous access for cannulation. Group 1 Only: * Currently pregnant, with an uncomplicated pregnancy as determined by the investigator or designee. * Estimated date of delivery within 24 weeks of screening. * Planned spontaneous vaginal birth and considered by investigator at low risk for post partum hemorrhage (PPH). * Planned birth in between the 37th and 42nd week of pregnancy. * Women who qualify for oxytocin as appropriate for active management of TSL and who agree to have active management. Group 2 Only: * ECG normal, or abnormal and not clinically signi…

What they're measuring

Part 1: Plasma Concentration Time Profile of Oxytocin

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin

Timeframe: 10 minutes post dose Day 1

Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin

Timeframe: 20 minutes post dose Day 1

Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin

Timeframe: 30 minutes post dose Day 1

Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin

Trial details

NCT IDNCT02999100

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-01

Results submitted2020-02-18

View on ClinicalTrials.gov More Postpartum Hemorrhage trials

Plain-language summary

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Plasma Concentration Time Profile of Oxytocin

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin

Timeframe: 10 minutes post dose Day 1

Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin

Timeframe: 20 minutes post dose Day 1

Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin

Timeframe: 30 minutes post dose Day 1

Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin