Oxytocin Dosing for Prolonged Labor

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, expected to be 2 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

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

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

Primary study objectives

Time to delivery

Secondary study objectives

Mode of delivery

Number of participants with nausea/vomiting requiring antiemetics and diarrhea

Number of participants with uterine tachysystole

+2 more

Awards & Highlights

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.

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.

Do I qualify?Apply below to find out