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Hormone Therapy

Oxytocin Delivery Methods for C-Section (INBOX Trial)

Phase 4

Recruiting

Led By Tiffany E Angelo, DO

Research Sponsored by Stony Brook University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2± 1 hours after surgery

Awards & highlights

Approved for 5 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Summary

This trial found that giving oxytocin as a bolus (a one-time dose) is better than giving it as an infusion (a continuous drip) in terms of how quickly it works to improve uterine tone.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Oxytocin can cause side effects such as nausea and vomiting; headache; rapid heartbeat; and flushing. Rarely it might lead to more serious issues like low blood pressure or strong contractions leading to uterine rupture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2± 1 hours after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2± 1 hours after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2± 1 hours after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number/Proportion of Participants with Adequate Uterine tone

Secondary study objectives

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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

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.

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