Skip to main content
OpenTrials
Completed

NCT Number: NCT04025658

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Twin Urogenital Diseases Uterine Hemorrhage

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Oxytocin

Drug

Oxytocin administered intravenously, over 1 minute following delivery of the fetal head

Other names: pitocin

Primary outcomes

  1. Uterine tone 2 minutes: questionnaire

    Time frame: 3 minutes

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

Secondary outcomes

  1. Need for uterine massage: questionnaire

    Time frame: 20 minutes

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

  2. Intraoperative requirement for additional uterotonic medication

    Time frame: 2 hours

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

  3. Calculated estimate of blood loss

    Time frame: 24 hours

    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

  4. Intravenous fluid administered during surgery

    Time frame: 2 hours

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

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

    Time frame: 2 hours

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

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

    Time frame: 2 hours

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

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

    Time frame: 2 hours

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

  8. Presence of ventricular tachycardia: ECG

    Time frame: 2 hours

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

  9. Presence of atrial fibrillation: ECG

    Time frame: 2 hours

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

  10. Presence of atrial flutter: ECG

    Time frame: 2 hours

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

  11. Presence of nausea: questionnaire

    Time frame: 2 hours

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

  12. Presence of vomiting: questionnaire

    Time frame: 2 hours

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

  13. Presence of chest pain: questionnaire

    Time frame: 2 hours

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

  14. Presence of shortness of breath: questionnaire

    Time frame: 2 hours

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

  15. Presence of headache: questionnaire

    Time frame: 2 hours

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

  16. Presence of flushing: questionnaire

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2019
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.