Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries

NCT04946006 | Completed

• 1 other identifier: 21-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Postpartum Hemorrhage

Keywords

Cesarean delivery; oxytocin; uterotonic; pregnancy

Outcome Measures

Primary Outcomes (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.

  2 hours

Secondary Outcomes (20)

• Calculated blood loss

  24 hours

• Incidence of post partum hemorrhage

  24 hours

• Need for blood transfusion

  24 hours

• Episodes of bleeding postpartum

  24 hours

• Intraoperative requirement for additional uterotonic medication

  2 hours

Study Arms (8)

Oxytocin infusion rate 2 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 2 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 4 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 4 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 6 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 6 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 8 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 8 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 10 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 10 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 12 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 12 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 14 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 14 IU/h.

Drug: Oxytocin

Oxytocin infusion rate 16 IU/h

EXPERIMENTAL

The maintenance infusion rate of oxytocin will be 16 IU/h.

Drug: Oxytocin

Interventions

Oxytocin DRUG

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

Also known as: Pitocin

Oxytocin infusion rate 10 IU/h; Oxytocin infusion rate 12 IU/h; Oxytocin infusion rate 14 IU/h; Oxytocin infusion rate 16 IU/h; Oxytocin infusion rate 2 IU/h; Oxytocin infusion rate 4 IU/h; Oxytocin infusion rate 6 IU/h; Oxytocin infusion rate 8 IU/h

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• 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.

  PMID: 39300008 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

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

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

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: June 25, 2021
• First Posted: June 30, 2021
• Study Start: July 26, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 2, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

CA (1)