Diphenhydramine for Labor Dystocia

(ACCEL Trial)

Overseen By Samantha Antonioli, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Category II/III tracing, Allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During labor

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to is to determine the clinical effectiveness of a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery in primiparous women undergoing trial of labor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug diphenhydramine for labor dystocia?

There is no direct evidence supporting the effectiveness of diphenhydramine for labor dystocia, but studies show it is effective as a sleep aid, improving sleep quality and reducing sleep latency in both adults and children. ^{1 2 3 4 5}

Is diphenhydramine safe for use in humans?

Diphenhydramine is generally considered safe for use in humans as an over-the-counter sleep aid, though it may cause side effects like drowsiness. Studies in both adults and children have shown it to be effective and safe for temporary sleep issues. ^{2 3 6 7 8}

How does the drug diphenhydramine differ from other treatments for labor dystocia?

Diphenhydramine is unique because it is primarily known as an over-the-counter sleep aid and antihistamine, commonly used to help with sleep issues and allergies. Its use in labor dystocia is novel, as it is not a standard treatment for this condition, which typically involves other medications or interventions to assist with labor progression. ^{2 3 4 8 9}

Research Team

Samantha Antonioli, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for first-time mothers undergoing labor who may be at risk of labor stopping and needing a cesarean delivery. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Primiparous

Category I tracing at time of inclusion

Ruptured membranes

Exclusion Criteria

Category II or III tracing

I am allergic to IV Diphenhydramine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery

During labor

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum complications and neonatal adverse events

6 weeks postpartum

Treatment Details

Interventions

• Diphenhydramine

Trial Overview The study is testing the effectiveness of an IV medication, Diphenhydramine, against usual care in preventing labor from stopping and reducing the need for cesarean deliveries in new mothers.

Participant Groups

Group I: Treatment with Diphenhydramine Experimental Treatment 2 Interventions

Group II: Usual Care Active Control 1 Intervention

Diphenhydramine is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Benadryl for:

• Allergic reactions
• Insomnia
• Motion sickness
• Coughs and colds

Approved in European Union as Diphenhydramine for:

• Allergic reactions
• Insomnia
• Motion sickness
• Coughs and colds

Approved in Canada as Unisom for:

• Insomnia
• Allergic reactions

Approved in Japan as Sominex for:

• Insomnia
• Allergic reactions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

In a study of 50 children with sleep disorders, diphenhydramine elixir (1.0 mg/kg) significantly reduced the time it took for children to fall asleep and the number of times they woke up during the night compared to a placebo.

Parents reported that diphenhydramine was more effective than placebo in improving overall sleep quality, indicating it is a safe and effective sleep aid for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of diphenhydramine HCI in pediatric sleep disorders. Russo, RM., Gururaj, VJ., Allen, JE.[2019]

In a study of 111 mildly to moderately insomniac patients, diphenhydramine (50 mg) significantly improved sleep parameters, such as reducing the time it took to fall asleep, compared to a placebo.

Despite experiencing more side effects, patients preferred diphenhydramine over placebo and reported feeling more rested the next morning, supporting its use as an effective over-the-counter sleep aid for temporary insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diphenhydramine in insomniac family practice patients: a double-blind study. Rickels, K., Morris, RJ., Newman, H., et al.[2019]

A study using PET imaging confirmed that diphenhydramine, a common over-the-counter sleep aid, has a significant next-day residual sedative effect, with 44.7% H₁ receptor occupancy in the brain compared to only 16.6% for the second-generation antihistamine bepotastine.

Despite the measurable sedative effects of diphenhydramine, subjective feelings of sleepiness did not differ significantly among participants, highlighting the importance of caution when using OTC antihistamines for sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-day residual sedative effect after nighttime administration of an over-the-counter antihistamine sleep aid, diphenhydramine, measured by positron emission tomography. Zhang, D., Tashiro, M., Shibuya, K., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Case of Massive Diphenhydramine and Naproxen Overdose. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of diphenhydramine HCI in pediatric sleep disorders. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Diphenhydramine in insomniac family practice patients: a double-blind study. [2019]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Factors associated with the use of over-the-counter sleep aids containing diphenhydramine: A cross-sectional study in Saudi Arabia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Use of Over-the-Counter Sleep Aid Containing Diphenhydramine Hydrochloride Among Saudis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a bedtime dose of a combination antihistamine/analgesic/decongestant product on antigen challenge the next morning. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Next-day residual sedative effect after nighttime administration of an over-the-counter antihistamine sleep aid, diphenhydramine, measured by positron emission tomography. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Pharmacokinetics and bioavailability of diphenhydramine in man]. [2013]