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Hormone Therapy

Oxytocin Dosing for Prolonged Labor

Q: What hazards do users of low-dose oxytocin face?

There is substantial evidence for the safety of low dose <a href="https://www.withpower.com/clinical-trials/oxytocin">oxytocin</a>, as it has already been approved by regulators; hence, Power rated it a 3 on their risk-scale.

Q: Are geriatric patients included in this trial?

The cut-off age for this medical trial is outlined in the inclusion criteria; applicants must be aged 18 or more, but not exceed 50 years old.

Q: Does this research endeavor still have room for participants?

Contrary to what was initially anticipated, data hosted on clinicaltrials.gov reveals that this medical investigation is not accepting patients at the moment. The study first appeared online on April 1st 2023 and its latest revision occurred on March 20th 2023. Happily, two other trials are actively searching for participants as of now.

Q: Is my participation in this research endeavor permissible?

Applicants to this clinical trial must have endured an extended period of labor and be between 18-50 years old. A total of 170 patients are expected to enroll in the study.

Phase 4

Recruiting

Led By Amanda Wang, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

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

Must have

Women aged 18-50 years old

No prior uterine surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, expected to be 2 years

Awards & highlights

Study Summary

This trial will compare outcomes of different infusion rates of oxytocin to induce or augment labor in nulliparous women.

Who is the study for?

This trial is for first-time mothers aged 18-50, at least 37 weeks pregnant with one baby in the head-down position, and no prior uterine surgery. They must be presenting for labor induction or need help speeding up their labor. Women can't join if they have a non-reassuring fetal heart rate, allergy to oxytocin, certain pregnancy complications like growth restriction of the fetus, contraindications to vaginal delivery or previous cervical ripening treatments.Check my eligibility

What is being tested?

The study compares low-dose versus high-dose oxytocin protocols for inducing and accelerating labor in women giving birth for the first time. One group will receive a starting dose of oxytocin at 2 milli-units/min increased every 20 minutes up to a max of 40 milli-units/min; the other starts at 6 milli-units/min with similar increases.See study design

What are the potential side effects?

Oxytocin may cause side effects such as intense contractions leading to fetal distress, changes in blood pressure, abnormal heartbeat patterns in mother or baby, water intoxication symptoms due to fluid retention (headache, nausea), and rarely rupture of the uterus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 50.

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I have never had surgery on my uterus.

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I need medication to help with labor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, expected to be 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, expected to be 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, expected to be 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to delivery

Secondary outcome measures

Maximum dose of oxytocin infusion

Mode of delivery

Number of neonates with one or more of: perinatal death, severe respiratory distress requiring ventilation, neonatal encephalopathy, neonatal seizure, neonatal sepsis, 5-minute APGAR score <7, umbilical artery acidemia, neonatal ICU admission

+11 more

Trial Design

2Treatment groups

Active Control

Group I: High dose oxytocinActive Control1 Intervention

The high dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 6 milli-units/min and will be increased by 6 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.

Group II: Low dose oxytocinActive Control1 Intervention

The low dose oxytocin group will receive a controlled infusion pump at a proximal port on the peripheral IV line. The infusion will start at 2 milli-units/min and will be increased by 2 milli-units/min every 20 minutes. Maximum rate of infusion is 40 milli-units/min. Oxytocin infusion rate is adjusted to maintain adequate uterine contractions.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor

241 Previous Clinical Trials

56,428 Total Patients Enrolled

Amanda Wang, MDPrincipal InvestigatorUniversity of Texas

Media Library

Oxytocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05782816 — Phase 4

Prolonged Labor Research Study Groups: High dose oxytocin, Low dose oxytocin

Prolonged Labor Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT05782816 — Phase 4

Oxytocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05782816 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hazards do users of low-dose oxytocin face?

"There is substantial evidence for the safety of low dose oxytocin, as it has already been approved by regulators; hence, Power rated it a 3 on their risk-scale."

Answered by AI

Are geriatric patients included in this trial?

"The cut-off age for this medical trial is outlined in the inclusion criteria; applicants must be aged 18 or more, but not exceed 50 years old."

Answered by AI

Does this research endeavor still have room for participants?

"Contrary to what was initially anticipated, data hosted on clinicaltrials.gov reveals that this medical investigation is not accepting patients at the moment. The study first appeared online on April 1st 2023 and its latest revision occurred on March 20th 2023. Happily, two other trials are actively searching for participants as of now."

Answered by AI

Is my participation in this research endeavor permissible?

"Applicants to this clinical trial must have endured an extended period of labor and be between 18-50 years old. A total of 170 patients are expected to enroll in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor

2023. "Low-Dose Versus High-Dose Oxytocin Dosing for Induction and Augmentation of Labor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05782816.

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