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Caffeine for Labor Management

Phase 1

Waitlist Available

Led By Daniel Jiang, MD

Research Sponsored by The Reading Hospital and Medical Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study Summary

This trial tests if caffeine & sodium benzoate can help reduce labor time in the 2nd stage of childbirth.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects from caffeine and sodium benzoate injection may include restlessness, heart palpitations, dizziness, and insomnia. Normal saline typically has no side effects but might cause mild irritation at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Reduction in maternal blood loss

Shortened second stage of labor

Secondary outcome measures

Fetal APGAR score

Incidence of operative delivery

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Caffeine and sodium benzoateExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The Reading Hospital and Medical CenterLead Sponsor

13 Previous Clinical Trials

1,456 Total Patients Enrolled

Daniel Jiang, MDPrincipal InvestigatorReading Hospital Tower Health

Media Library

Caffeine in the Second Stage of Labor (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05906303 — Phase 1

Labour Research Study Groups: Caffeine and sodium benzoate, Placebo

Labour Clinical Trial 2023: Caffeine in the Second Stage of Labor Highlights & Side Effects. Trial Name: NCT05906303 — Phase 1

Caffeine in the Second Stage of Labor (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05906303 — Phase 1

Frequently Asked Questions

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

Are participants being accepted into this experiment presently?

"The listing on clinicaltrials.gov denotes that this particular medical study is not currently recruiting, having been posted August 1st 2023 and updated June 21st 2023. Nevertheless, two other trials are presently enrolling research participants."

Answered by AI

Has the Federal Drug Administration sanctioned Caffeine and sodium benzoate?

"As the trial is now in Phase 1, our internal evaluation of Caffeine and sodium benzoate's safety scored a 1 due to sparse data confirming its efficacy."

Answered by AI

Recent research and studies

MedicinaJournal

Correlation Between Maternal Weight Gain in Each Trimester and Fetal Growth According to Pre-pregnancy Maternal Body Mass Index in Twin Pregnancies

Kim, Mi Ju, Hyun Mi Kim, Hyun-Hwa Cha, and Won Joon Seong. 2022. “Correlation Between Maternal Weight Gain in Each Trimester and Fetal Growth According to Pre-pregnancy Maternal Body Mass Index in Twin Pregnancies”. Medicina. MDPI AG. doi:10.3390/medicina58091209.

Obstetrics & GynecologyJournal

Operative Vaginal Birth

“Operative Vaginal Birth”. 2020. “Operative Vaginal Birth”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000003764.

clinicaltrials.govStudy

Caffeine in the Second Stage of Labor in Low-risk Nulliparous Mothers at Term

2023. "Caffeine in the Second Stage of Labor in Low-risk Nulliparous Mothers at Term". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05906303.