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Postpartum HemorrhageNCT04025658

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy

A study testing Oxytocin in people with Postpartum Hemorrhage and Twin, 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

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth and these are effective at reducing the incidence of PPH. 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, Twin
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
30 participants
Where
1 siteCanada
Study dates
6 Aug 2019to 8 Sep 2021
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

  • Twin pregnancy
  • Elective cesarean delivery under regional anesthesia
  • Gestational age ≥36 weeks
  • No known additional risk factors for postpartum hemorrhage
  • Written informed consent to participate in this study

Who cannot join

  • Refusal to give written informed consent
  • Allergy or hypersensitivity to oxytocin
  • Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40
  • Hepatic, renal, and vascular disease
  • Use of general anesthesia prior to the administration of the study drug

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mount Sinai Hospital

    Toronto, Ontario, M5G1X5

Other trials in Canada

About this study

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth and these are effective at reducing the incidence of PPH. Large doses of this drug are associated with adverse effects like lower blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage.

The investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately.

Read the detailed description

Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. Furthermore, recent evidence has shown that the rate of PPH secondary to uterine atony is increasing.

Multiple pregnancy is a well-recognized risk factor for PPH. Compared with singleton pregnancy, women with a multiple pregnancy have an increased risk of PPH, severe PPH, transfusion, uterine atony, hysterectomy, prolonged hospital stay and death. This is true in both high- and low-income countries. Uterine atony as a cause of PPH is more likely in multiple pregnancy compared with singleton pregnancy.

Prophylactic uterotonic drugs administered after the delivery have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly administered uterotonic drug used to prevent PPH in North America but is associated with adverse effects such as hypotension, nausea, vomiting, dysrhythmias, ST segment abnormalities, and severe water intoxication that may lead to pulmonary edema and convulsions.

Previous dose finding studies have excluded women with twin pregnancies. Therefore, the investigators wish to perform a double blinded dose finding study using the biased coin flip up-and-down sequential allocation technique to determine the ED 90 of oxytocin at cesarean section in those women with a twin pregnancy.

Being tested
Oxytocin
Keywords
pregnancy, twin, postpartum hemorrhage, oxytocin, Cesarean delivery
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 administered intravenously, over 1 minute following delivery of the fetal head

Study groups in NCT04025658
Study groupRoleWhat they receive
Oxytocin 0.5IUActive comparatorPatient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Receives: Drug: Oxytocin
Oxytocin 1IUActive comparatorPatient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Receives: Drug: Oxytocin
Oxytocin 2IUActive comparatorPatient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Receives: Drug: Oxytocin
Oxytocin 3IUActive comparatorPatient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Receives: Drug: Oxytocin
Oxytocin 4IUActive comparatorPatient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Receives: Drug: Oxytocin
Oxytocin 5IUActive comparatorPatient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Receives: Drug: Oxytocin

What is being measured

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

  1. Uterine tone 2 minutes: questionnaire

    Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).

    Measured: 3 minutes

Secondary outcomes (16)

  1. Need for uterine massage: questionnaire

    The obstetricians will be asked if there was any need for uterine massage beyond the initial 3 minute evaluation period following delivery.

    Measured: 20 minutes

  2. 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

  3. Calculated estimate of blood loss

    Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean delivery, according to the following formula:

    Calculated blood loss = 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

  4. Intravenous fluid administered during surgery

    The total volume (ml) of fluid administered from entering the operating room to skin closure.

    Measured: 2 hours

  5. 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

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

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

    Measured: 2 hours

  7. 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

  8. Presence of ventricular tachycardia: ECG

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

    Measured: 2 hours

  9. Presence of atrial fibrillation: ECG

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

    Measured: 2 hours

  10. Presence of atrial flutter: ECG

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

    Measured: 2 hours

  11. 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

  12. Presence of vomiting: questionnaire

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

    Measured: 2 hours

  13. 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

  14. 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

  15. Presence of headache: questionnaire

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

    Measured: 2 hours

  16. Presence of flushing: questionnaire

    Any presence of flushing, from drug administration until end of surgery

    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 posted19 Jul 2019
  2. Study start6 Aug 2019
  3. Primary completion7 Sep 2021
  4. Study completion8 Sep 2021

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
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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025658
Sponsor's protocol ID
19-03
Status last verified
Jan 2022
First submitted
17 Jul 2019
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Peska E, Balki M, Pfeifer W, Maxwell C, Ye XY, Downey K, Carvalho JCA. Oxytocin at Elective Cesarean Delivery: A Dose-Finding Study in Pregnant People With Twin Pregnancy. Anesth Analg. 2024 Apr 1;138(4):814-820. doi: 10.1213/ANE.0000000000006309. Epub 2022 Dec 8.

    PubMed 36480452

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin in people with Postpartum Hemorrhage and Twin, 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 5 inclusion and 5 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 28 Jan 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 2 minutes: questionnaire (time frame: 3 minutes). 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 NCT04025658, 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 28 Jan 2022.

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