Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

NCT03957083 | Completed

• 1 other identifier: 19-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. Oxytocin is the most commonly used uterotonic drug to prevent and treat PPH. Large doses of this drug are asociated with adverse effects like low 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 dose of oxytocin is required (ED95 being 0.35IU). However, most of the women included in this study were below a body mass index (BMI) of 40kg/m2. The investigators seek to find the best dose for patients with a BMI\>40kg/m2, as a higher dose may be needed in this population to contract the uterus adequately.

Conditions

Postpartum Hemorrhage; Obesity

Keywords

pregnancy; postpartum hemorrhage; Cesarean delivery; oxytocin; obesity

Outcome Measures

Primary Outcomes (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.

  2 minutes

Secondary Outcomes (16)

• Need for uterine massage: questionnaire

  20 minute

• Intraoperative requirement for additional uterotonic medication

  1 hour

• Calculated estimate of blood loss

  24 hours

• Intravenous fluid administered during surgery

  2 hours

• Hypotension: systolic blood pressure less than 80% of baseline

  2 hours

Study Arms (6)

Oxytocin 0.5IU

ACTIVE COMPARATOR

Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Oxytocin

Oxytocin 1IU

ACTIVE COMPARATOR

Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Oxytocin

Oxytocin 2IU

ACTIVE COMPARATOR

Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Oxytocin

Oxytocin 3IU

ACTIVE COMPARATOR

Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Oxytocin

Oxytocin 4IU

ACTIVE COMPARATOR

Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Oxytocin

Oxytocin 5IU

ACTIVE COMPARATOR

Patient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Drug: Oxytocin

Interventions

Oxytocin DRUG

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

Also known as: pitocin

Oxytocin 0.5IU; Oxytocin 1IU; Oxytocin 2IU; Oxytocin 3IU; Oxytocin 4IU; Oxytocin 5IU

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥40kg/m2
• Elective cesarean delivery under regional anesthesia
• Gestational age ≥ 37 weeks
• No known additional risk factors for postpartum hemorrhage
• Written informed consent to participate in this study

You may not qualify if:

• Refusal to give written informed consent
• Allergy or hypersensitivity to oxytocin
• Conditions (other than high BMI) that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, severe preeclampsia (as defined by SOGC guidelines (21)), eclampsia, polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis.
• Hepatic, renal, and vascular disease
• Use of general anesthesia prior to the administration of the study drug

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Obesity

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biased coin up-and-down design.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: June 26, 2019
• Primary Completion: February 3, 2020
• Study Completion: February 4, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)