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Postpartum HemorrhageNCT04946006

Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries

A study testing Oxytocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Postpartum Hemorrhage
What is being tested?
Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
26 Jul 2021to 2 Apr 2022
Phase
Interventional
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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Elective uncomplicated cesarean delivery under neuraxial anesthesia
  • >18 year-old with ASA status II or III, with a singleton gestation and a gestational age between 37 to 42 weeks Informed consent to participate in this study

Who cannot join

  • Refusal to give written informed consent
  • Allergy or hypersensitivity to oxytocin
  • Body mass index ≥ 40 kg/m2on the day of admission
  • A history of hypertension and/ or severe cardiac disease(s)
  • Contra-indications for neuraxial anesthesia
  • Conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, macrosomia (≥ 4 kg), polyhydramnios, uterine fibroids in and near operating field, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5

Other trials in Canada

About this study

Official title: Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries: an Up-down Sequential Allocation Dose-response Study

This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. If the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. The dose for the next patient will be determined based on the results of the uterine contraction of the previous patient.

The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 IU/h).

Read the detailed description

This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in non-laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90.

Being tested
Oxytocin
Keywords
Cesarean delivery, oxytocin, uterotonic, pregnancy
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

    Also called Pitocin

    Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h.

Study groups in NCT04946006
Study groupRoleWhat they receive
Oxytocin infusion rate 2 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 2 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 4 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 4 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 6 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 6 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 8 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 8 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 10 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 10 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 12 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 12 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 14 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 14 IU/h.
Receives: Drug: Oxytocin
Oxytocin infusion rate 16 IU/hExperimentalThe maintenance infusion rate of oxytocin will be 16 IU/h.
Receives: Drug: Oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uterine tone upon discharge from the post anesthetic care unit (PACU): questionnaire

    Uterine tone will be evaluated as satisfactory or unsatisfactory by the obstetrician throughout the surgery, starting at 5 minutes after the oxytocin infusion. It will also be measured at 10 minutes following the oxytocin infusion and every 10 minutes following that for the duration of the surgery. Unsatisfactory uterine tone at any time until discharge from the PACU will be considered a failure of the maintenance infusion.

    Measured: 2 hours

Secondary outcomes (20)

  1. Calculated blood loss

    Estimated blood loss will be calculated using the difference in hematocrit values prior to surgery and 24 hours post surgery, using the following formula:

    Calculated blood loss (mL) = EBV ((Pre-op Htc-Post-op Htc)/pre-op Htc) EBV (estimated blood volume) in ml: patient's weight in kg x 85.

    Measured: 24 hours

  2. Incidence of post partum hemorrhage

    Incidence of post partum hemorrhage defined as a calculated blood loss >1L.

    Measured: 24 hours

  3. Need for blood transfusion

    Blood product administered.

    Measured: 24 hours

  4. Episodes of bleeding postpartum

    Number of episodes of bleeding postpartum up to 24 hours post delivery.

    Measured: 24 hours

  5. Intraoperative requirement for additional uterotonic medication

    A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.

    Measured: 2 hours

  6. Requirement for additional uterotonic medication in the PACU

    Any uterotonic medication administered while the patient is in PACU

    Measured: 2 hours

  7. Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.

    Any uterotonic medication administered after the patient is discharged from PACU until 24 hours postpartum.

    Measured: 24 hours

  8. Postoperative uterine position in the PACU

    Postoperative uterine position (below or above the umbilicus) as determined by the PACU nurse. This is measured every 15 minutes for the first hour and then hourly until discharge to the postpartum unit.

    Measured: 3 hours

  9. Hypotension: systolic blood pressure less than 80% of baseline

    Systolic blood pressure < 80% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  10. Hypertension: systolic blood pressure greater than 120% of baseline

    Systolic blood pressure > 120% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  11. Tachycardia: heart rate greater than 130% of baseline

    Heart rate > 130% of baseline, from drug administration until end of surgery

    Measured: 2 hours

  12. Bradycardia: heart rate less than 70% of baseline

    Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery

    Measured: 2 hours

  13. Presence of ventricular tachycardia: ECG

    Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery

    Measured: 2 hours

  14. Presence of atrial fibrillation: ECG

    Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery

    Measured: 2 hours

  15. Presence of atrial flutter: ECG

    Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery

    Measured: 2 hours

  16. Presence of nausea: questionnaire

    The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  17. Presence of vomiting: questionnaire

    The presence of vomiting and number of episodes, from drug administration until end of surgery

    Measured: 2 hours

  18. Presence of chest pain: questionnaire

    Any presence of chest pain, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  19. Presence of shortness of breath: questionnaire

    Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

  20. Presence of headache: questionnaire

    Any presence of headache, from drug administration until end of surgery, as reported by the patient

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start26 Jul 2021
  3. Primary completion1 Apr 2022
  4. Study completion2 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Biased coin up-and-down design.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04946006
Sponsor's protocol ID
21-05
Status last verified
Jun 2022
First submitted
25 Jun 2021
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Boonstra L, Carvalho JCA, Turner W, Downey K, Ye XY, Thomas J, Balki M. Maintenance infusion rate of oxytocin after initial 1-IU bolus for elective Cesarean delivery: a dose-finding study. Can J Anaesth. 2024 Oct;71(10):1363-1371. doi: 10.1007/s12630-024-02828-9. Epub 2024 Sep 19.

    PubMed 39300008

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.

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 2 inclusion and 6 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 Jun 2022. 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 Canada. 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?

Uterine tone upon discharge from the post anesthetic care unit (PACU): questionnaire (time frame: 2 hours). 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 NCT04946006, which also lists 1 linked publication.

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 Jun 2022.

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