Postpartum HemorrhagePeacocksNCT03898882
Pharmacokinetics of Oxytocin at Cesarean Delivery
An observational study of Postpartum Hemorrhage, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- oxytocin and Shore durometer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women scheduled for cesarean delivery of their babies at term
Who may be able to join
- Term singleton pregnancy
- Age 18-45 years of age
- ASA classification 2 or 3
- Scheduled cesarean delivery under neuraxial anaesthesia
Who cannot join
- Age or ASA classification outside of inclusion criteria
- Need for general anaesthesia
- Absence of consent
- Inability to communicate in English or other barrier to providing informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: The Pharmacokinetics of Oxytocin in Pregnant Women Undergoing Cesarean Delivery - a Feasibility Pilot Study
The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice.
Read the detailed description
In this pilot study the investigators will compare plasma oxytocin concentrations measured in arterial and venous blood, after oxytocin administration at cesarean delivery, in order to assess the validity of venous samples. They will also measure oxytocinase to explore how levels vary around the time of delivery of the placenta and to assess the effect that this may have on the metabolism of oxytocin.
- Conditions
- Postpartum Hemorrhage
- Being tested
- oxytocin, Shore durometer
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
PK measurements of oxytocin
Shore durometerDevice
The investigators will take serial readings from a digital durometer at the uterine fundus at 3, 6, 9 and 12 minutes following OXT administration to provide data that will inform an estimate of the timing of peak effect. Shore durometers measure the hardness of materials on a scale of 0-100 Shore Units (SU). Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery. Durometer readings were also shown to correlate positively with the obstetrician's manual assessment of uterine contractility, which is traditionally used to determine the success or failure of uterotonic therapy.
| Study group | Role | What they receive |
|---|---|---|
| BMI 20 - 29.9 kg/m2 | Not described Receives: Drug: oxytocin; Device: Shore durometer | |
| BMI > 30 kg/m2 | Not described Receives: Drug: oxytocin; Device: Shore durometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial [OXT]
Concentration of oxytocin in arterial samples
Measured: Scheduled samples during the first 30 minutes after oxytocin administration
Venous [OXT]
Concentration of oxytocin in venous samples
Measured: Scheduled samples during the first 30 minutes after oxytocin administration
Secondary outcomes (5)
Arterial [OXTase]
Concentration of oxytocinase in arterial samples
Measured: Scheduled samples during the first 30 minutes after oxytocin administration
Uterine tone
Uterine tone measured using a Shore Durometer or assessed by obstetrician using numerical rating score (NRS, 0-10)
Measured: Scheduled measurements during the first 30 minutes after oxytocin administration
Hypotension
Incidence of systolic BP reduced by 20% from baseline
Measured: Measured intraoperatively
Nausea & Vomiting
Incidence of nausea and vomiting
Measured: Recorded intraoperatively
EBL
Estimated blood loss in milliliters
Measured: Estimated at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start24 May 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David T Monks, MBChB, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898882
- Sponsor's protocol ID
- 201810134
- Acronym
- Peacocks
- Status last verified
- May 2020
- First submitted
- 29 Mar 2019
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PubMed 25103301Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.
PubMed 20482535Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part II). Clin Pharmacokinet. 1989 Oct;17(4):275-90. doi: 10.2165/00003088-198917040-00005. No abstract available.
PubMed 2686884Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part I). Clin Pharmacokinet. 1989 Sep;17(3):175-99. doi: 10.2165/00003088-198917030-00004.
PubMed 2680213
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Oxytocin in Pregnant Women Undergoing Cesarean Delivery - a Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT03898882
- Acronym / sponsor ID
- Peacocks / 201810134
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice.
Detailed description
In this pilot study the investigators will compare plasma oxytocin concentrations measured in arterial and venous blood, after oxytocin administration at cesarean delivery, in order to assess the validity of venous samples. They will also measure oxytocinase to explore how levels vary around the time of delivery of the placenta and to assess the effect that this may have on the metabolism of oxytocin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI 20 - 29.9 kg/m2 | – | Drug: oxytocin, Device: Shore durometer |
| BMI > 30 kg/m2 | – | Drug: oxytocin, Device: Shore durometer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women scheduled for cesarean delivery of their babies at term
Key inclusion criteria (4 listed)
- Term singleton pregnancy
- Age 18-45 years of age
- ASA classification 2 or 3
- Scheduled cesarean delivery under neuraxial anaesthesia
Key exclusion criteria (4 listed)
- Age or ASA classification outside of inclusion criteria
- Need for general anaesthesia
- Absence of consent
- Inability to communicate in English or other barrier to providing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocinPK measurements of oxytocin | Drug | BMI 20 - 29.9 kg/m2, BMI > 30 kg/m2 |
| Shore durometerThe investigators will take serial readings from a digital durometer at the uterine fundus at 3, 6, 9 and 12 minutes following OXT administration to provide data that will inform an estimate of the timing of peak effect. Shore durometers measure the hardness of materials on a scale of 0-100 Shore Units (SU). Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery. Durometer readings were also shown to correlate positively with the obstetrician's manual assessment of uterine contractility, which is traditionally used to determine the success or failure of uterotonic therapy. | Device | BMI 20 - 29.9 kg/m2, BMI > 30 kg/m2 |
Primary outcome
Arterial [OXT]
Time frame: Scheduled samples during the first 30 minutes after oxytocin administration
Concentration of oxytocin in arterial samples
Venous [OXT]
Time frame: Scheduled samples during the first 30 minutes after oxytocin administration
Concentration of oxytocin in venous samples
5 secondary outcomes
Arterial [OXTase]
Time frame: Scheduled samples during the first 30 minutes after oxytocin administration
Uterine tone
Time frame: Scheduled measurements during the first 30 minutes after oxytocin administration
Hypotension
Time frame: Measured intraoperatively
Nausea & Vomiting
Time frame: Recorded intraoperatively
EBL
Time frame: Estimated at the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Background: PubMed 25103301Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Background: PubMed 20482535Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.
- Background: PubMed 2686884Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part II). Clin Pharmacokinet. 1989 Oct;17(4):275-90. doi: 10.2165/00003088-198917040-00005. No abstract available.
- Background: PubMed 2680213Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part I). Clin Pharmacokinet. 1989 Sep;17(3):175-99. doi: 10.2165/00003088-198917030-00004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David T Monks, MBChB principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial [OXT] (time frame: Scheduled samples during the first 30 minutes after oxytocin administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898882, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.