Oxytocin Delivery Methods for C-Section
(INBOX Trial)

Recruiting in Palo Alto (17 mi)

Overseen byTiffany E Angelo, DO

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Stony Brook University

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.

Eligibility Criteria

This trial is for women aged 18-45, with a single baby pregnancy, planning an elective C-section under spinal anesthesia. They should be generally healthy (ASA class I or II) and able to consent. It's not for those in labor, with multiple babies, at risk of weak uterine tone due to conditions like preeclampsia or diabetes, previous severe bleeding after birth, blood disorders including low platelets or anemia, allergy to oxytocin, or unable to understand the study.

Inclusion Criteria

American Society of Anesthesia (ASA) physical status class I or II

Patients must be able to provide written informed consent

Parturients between the ages of 18 to 45 with singleton pregnancies

+1 more

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)

+4 more

Participant Groups

The trial is testing two ways of giving oxytocin during a planned C-section: as a quick injection (bolus) versus a slow drip (infusion). The goal is to see which method is better at making the uterus firm quickly after delivery.

2Treatment groups

Active Control

Group I: Bolus armActive Control1 Intervention

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.

Group II: Infusion armActive Control1 Intervention

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.

Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Pitocin for: