Caffeine for Labor Management

Overseen By Angel Marquez, DO

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: The Reading Hospital and Medical Center

Must not be taking: Cocaine, Amphetamines

Disqualifiers: Hypertension, Cardiac history, Drug use, others

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Single blind, randomized control trial to determine benefit of caffeine and sodium benzoate on the second stage of labor

Research Team

Daniel Jiang, MD

Principal Investigator

Reading Hospital Tower Health

Eligibility Criteria

This trial is for first-time pregnant mothers at term (37 weeks or more), who have a way to receive medications through their veins. It's not suitable for those with certain conditions that aren't listed here.

Inclusion Criteria

Patients receiving prenatal care at Tower Health Obstetrical practices

I am a pregnant woman at or past 37 weeks, aged 18-45, with an IV line.

Exclusion Criteria

Fetal malpresentation

I have a history of serious heart conditions.

Positive drug screen on admission for cocaine or amphetamines

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Starting at 36 weeks gestation

1 visit (in-person)

Treatment

Administration of either 500 cc normal saline or 250 mg of caffeine sodium benzoate during the second stage of labor

2 hours

During labor

Follow-up

Participants are monitored for safety and effectiveness after treatment, including reduction in maternal blood loss and incidence of operative delivery

one year

Treatment Details

Interventions

• Caffeine in the Second Stage of Labor

Trial Overview The study is testing if an injection of caffeine and sodium benzoate can help during the second stage of labor, when the mother pushes out the baby. Participants are randomly given either this injection or a normal saline solution without knowing which one they received.

Participant Groups

Group I: Caffeine and sodium benzoate Experimental Treatment 1 Intervention

Patients will received 250 mg IV caffeine and sodium benzoate (125 mg each) dissolved in 500 cc normal saline which will be administered over the course of two hours upon determination the patient is 10 cm in cervical dilation.

Group II: Placebo Placebo Group 1 Intervention

Patients will received 500 cc normal saline which will be administered over the course of two hours upon determination the patient is 10 cm in cervical dilation.

Who Is Running the Clinical Trial?

The Reading Hospital and Medical Center

Lead Sponsor

Trials

14

Recruited

1,500+