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Trial · Interventional

Status unknownPhase 4Registry data

Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

Short name INBOX

NCTNCT05236985 (opens ClinicalTrials.gov in a new tab)Other idIRB 2021-00558
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
120 participants (estimated)
Sponsor
Stony Brook University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
15 Mar 2022
Primary completion
15 Dec 2024 (estimated)
Completion
15 Dec 2024 (estimated)
First posted
11 Feb 2022
Last update posted
15 Mar 2024
Conditions
Elective Cesarean Section

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 4

    INBOX

    NCT05236985

    15 Mar 2022 to est. 15 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.

Interventions

  • Oxytocin bolus or oxytocin infusionDrug

Arms2

  • Active comparator

    Bolus arm

    Patients will receive 3 IU oxytocin IV bolus over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 0.9% Saline will be started at 225ml/hr. If uterine tone is inadequate after 3 minutes, a second bolus of 3 IU oxytocin will be given. If uterine tone is inadequate after an additional 3 minutes, a third bolus of 3 IU Oxytocin IV is given over 15 seconds. If after an additional 3 mins uterine tone is still inadequate, a second infusion consisting of oxytocin 3 IU/hr is started at 100ml/hrs and continued for a total of 4 hours, second line uterotonic agents (Methergine, Hemabate and/ or Cytotec) will be given, and the maintenance 0.9% Saline infusion will be changed to 450 ml/hr for a total of 1 hour, then changed to 38 ml/ hour for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of oxytocin 3 IU/hr (100ml/hr) is started and maintained for 4 hours.

  • Active comparator

    Infusion arm

    Patients will receive a bolus of IV 0.9% Saline over 15 seconds after delivery of the baby/uterine cord clamping and a maintenance infusion of 18 IU/hr Oxytocin IV (225ml/hr). If uterine tone is inadequate after 3 minutes, a second bolus of 0.9% Saline will be given. If uterine tone is inadequate after another 3 minutes, a third bolus of 0.9% Saline will be given. If after another 3 mins uterine tone is inadequate, a second infusion of 0.9% Saline will be started for 4 hours, second line uterotonic agents (Methergine, Hemabate and/or Cytotec) will be given, and the Oxytocin infusion will be changed to 36 IU/hour (450 ml/hr) for a total of 1 hour, and then changed to 38 ml/hr for the following 3 hours. If uterine tone is considered adequate at 3, 6 or 9 minutes, a second infusion of 0.9% Saline at 100 ml/hr will be started and maintained for 4 hours, along with the maintenance infusion of 18 IU/hr (225 ml/ hr) for a total of 1 hour, then changed to 38 ml/hr for an additional 3 hours.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number/Proportion of Participants with Adequate Uterine tone

    Time frame · 2 minutes

    Registry description

    Adequacy of uterine tone (yes/no) at 2 minutes after the baby is born/umbilical cord clamped.

Secondary outcomes(1)

  1. Patient satisfaction questionnaire (Scale 0 to 10, 0 being complete dissatisfaction and 10 being highly satisfied

    Time frame · 2± 1 hours after surgery

    Registry description

    Patients will complete a questionnaire 2± 1 hours after surgery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

More studies

4 studies on this page

PubMed tag: none · 2020

A randomised double-blind trial of minimal bolus doses of oxytocin for elective caesarean section under spinal anaesthesia: Optimal or not?

Joseph et al. 2020Indian journal of anaesthesiacited by 4

PMID 33487681PMC7815013DOI 10.4103/ija.ija_377_20PUB-33487681

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Observational study · 2017

An observational cohort study of 3 units versus 5 units slow intravenous bolus oxytocin in women undergoing elective caesarean delivery.

Terblanche et al. 2017Journal of physiology and pharmacology : an official journal of the Polish Physiological Societycited by 5

PMID 29151071PUB-29151071

Full text at the publisher
Publisher page

PubMed tag: none · 2014

Oxytocin protocols for cesarean delivery.

Balki et al. 2014International anesthesiology clinicscited by 14

PMID 24667448DOI 10.1097/aia.0000000000000016PUB-24667448

Full text at the publisher
Publisher page

PubMed tag: none · 1984

Oxytocin receptors in the human uterus during pregnancy and parturition.

Fuchs et al. 1984American journal of obstetrics and gynecologycited by 344

PMID 6093538DOI 10.1016/0002-9378(84)90677-xPUB-06093538

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Parturients between the ages of 18 to 45 with singleton pregnancies * Undergoing elective cesarean section under spinal anesthesia * American Society of Anesthesia (ASA) physical status class I or II * Patients must be able to provide written informed consent Exclusion Criteria: * Parturients in labor or ruptured membranes * Multiple gestation * Risk factors predisposing to uterine atony (history of placenta previa, preeclampsia, diabetes mellitus macrosomia, hydramnios, bleeding diathesis, uterine fibroids) * History of uterine atony or postpartum hemorrhage * History of inherited or acquired coagulation disorders, thrombocytopenia (platelet count \<100), or anemia (hemoglobin \< 8) * History of allergy to oxytocin * Patients not alert and orientated to person, place, and date. Patient must have, in the investigator's opinion, the physical and mental capacity to answer survey questions

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