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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether caffeine can aid in managing the second stage of labor, when the mother pushes and delivers the baby. Researchers are testing if caffeine, combined with sodium benzoate, can make this stage smoother or faster. Participants will receive either this caffeine mixture or a placebo (a harmless, inactive substance) through an IV. The trial seeks first-time pregnant women who are at least 37 weeks along and receiving prenatal care at Tower Health. Those with high blood pressure, significant heart issues, or other specified conditions will not be eligible. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that caffeine and sodium benzoate are usually safe for people. Some studies found that when administered through an IV, caffeine sodium benzoate can reduce headaches and boost mood and energy. These effects might be beneficial during labor.

However, this trial is in an early stage, so limited information exists about its safety specifically during labor. This phase primarily aims to understand how the treatment works in the body and its safety for participants. Any serious side effects from earlier research would likely have been reported by now.

While positive signs exist, participants in this trial will help researchers learn more about the safety of caffeine and sodium benzoate for managing labor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using caffeine in the second stage of labor because it introduces a novel approach to labor management. Unlike traditional methods like oxytocin or epidurals, which focus on inducing contractions or managing pain, caffeine has the potential to enhance muscle endurance and alertness without the sedative effects. This could help reduce fatigue in birthing individuals, potentially leading to more efficient labor progression. Additionally, caffeine's well-known safety profile and quick action make it an intriguing candidate for improving labor experiences.

What evidence suggests that caffeine might be an effective treatment for labor management?

In this trial, participants will receive either a placebo or a combination of caffeine and sodium benzoate during the second stage of labor. Research has shown that caffeine, when combined with sodium benzoate, might be beneficial during this stage. This combination has been found to boost energy and improve mood, potentially making the pushing stage more effective. Caffeine is known to enhance physical performance, which might reduce the need for surgical intervention. While caffeine and sodium benzoate are already used for conditions like headaches, their role in labor remains under study. Early evidence suggests they could shorten and ease the second stage of labor for mothers. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel Jiang, MD

Principal Investigator

Reading Hospital Tower Health

Are You a Good Fit for This Trial?

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

Lack of prenatal care

Positive drug screen on admission for cocaine or amphetamines

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05906303?term=AREA%5BInterventionSearch%5D(SODIUM%20BENZOATE)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=10

Caffeine in the Second Stage of Labor in Low-risk ... The provision of caffeine may improve energy, mood and physiologic performance and reduce the incidence of operative deliveries, shorten the second stage of ...

2. withpower.com withpower.com/trial/phase-1-second-stage-of-labour-7-2023-6318b

Caffeine for Labor Management · Info for Participants 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 ...

3. archive.hshsl.umaryland.edu archive.hshsl.umaryland.edu/bitstreams/4f65700d-cad8-4ef6-b035-6089125a568a/download

Caffeine and sodium benzoate Outcome measures differed among the included studies and included: relief of headache, risk factors for developing post-dural puncture headache (PDPH), ...

4. sciencedirect.com sciencedirect.com/topics/neuroscience/caffeine-benzoate

Caffeine Benzoate - an overview It has shown effectiveness in treating Post-Dural Puncture Headache (PDPH) when other treatments are ineffective.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960508/

Management of Post-Dural Puncture Headaches in Pediatric ... Both oral and IV caffeine sodium benzoate formulations may result in a transient reduction in pain scores. Oral caffeine is well absorbed ...

6. quizlet.com quizlet.com/456439850/hesi-cs-postpartum-flash-cards/

HESI CS: Postpartum Flashcards Prior to administering the medications to Marie, which information should the nurse include about caffeine and sodium benzoate? Caffeine and sodium benzoate ...

7. quizlet.com quizlet.com/923686026/hesi-case-study-_-postpartum-flash-cards/

HESI Case Study _ Postpartum Flashcards Caffeine and sodium benzoate will constrict the cerebral blood vessels and decrease the headache. Prior to administering the medication, the nurse should ...