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

September 12, 2023 updated by: The Reading Hospital and Medical Center

Caffeine in the Second Stage: A Randomized Control Trial in Low-risk Nulliparous Mothers at Term

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will present to the Women's Health Center as part of their prenatal visits or to Labor and Delivery for induction of labor or in spontaneous labor. Starting at 36 weeks gestation in the clinic or upon arrival to the labor floor, the inclusion criteria specified above will be applied by the OB Resident. Upon meeting criteria, the OB Resident will speak to the patient and gather any information typically needed for their visit/admission. Upon conclusion of the visit/admission, the OB Resident will discuss the consent form with the patient and inquire about interest to participate in the study. If interested in participation, the consent form will be signed by the patient, the resident, and a witness. At that time the patient will be designated a number for tracking purposes and a caffeine food frequency questionnaire will be completed. Patients who are involved in the study will have their problem list updated for tracking and will be designated on the labor board at time of arrival to maintain continuity of care within and across shifts. At time of arrival to the labor floor the OB resident with confirm desire to proceed with the study and record caffeine intake on the day of admission. Based on the previously assigned number, the patient will be placed into the treatment or placebo arm based upon a randomization schedule held by the OB resident team. At the time of labor, patient management will take place by the OB team with no impact by study involvement. At the time the patient is noted to be 10 cm dilated administration of either 500 cc normal saline (NS) or 250 mg of caffeine sodium benzoate (125 mg caffeine, 125 mg sodium benzoate) in 500 cc NS over 2 hours at a rate of 250 ml/hr will be performed. The time the intervention is given will be annotated on the labor board. The solutions will be kept in the hospital pharmacy and will be sent to the labor floor upon placement of the order in epic by the OB resident. The length of the second stage as well as the time and method of delivery, indication, blood loss and fetal APGARs will be documented in EPIC as part of the normal flow of documentation. All data will be extrapolated from EPIC, de-identified and stored in REDCap for organization and application of data analysis.

The intent of this project is to utilize a well-studied substance with the potential to improve cognitive and physiologic performance in a novel setting for a population that has a baseline risk for morbidity. The length of the overall labor process often results in a state of exhaustion for mothers prior to being required to spend potentially 2-4 hours actively pushing. The provision of caffeine may improve energy, mood and physiologic performance and reduce the incidence of operative deliveries, shorten the second stage of labor and reduce maternal blood loss. If the results of this study are demonstrated to be significant, the administration of caffeine is a low-risk intervention that may be considered for implementation across populations and potentially reduce maternal morbidity worldwide.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital Labor & Delivery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Nulliparous pregnant mothers at term (37 weeks gestation and above), 18-45 years of age, intravenous access. Patients receiving prenatal care at Tower Health Obstetrical practices.

Exclusion Criteria:

  • Hypertensive disorders (chronic hypertension, gestation hypertension, pre-eclampsia, HELLP syndrome; hypertension defined as a systolic blood pressure of 140 mmHg or diastolic blood pressure of 90 mmHg collected on two occasions four hours apart. Upon a new diagnosis of gestational hypertension, the patients would then be excluded. Chronic hypertensive patients are excluded by default.), significant cardiac history (history of myocardial infarction, stroke, arrhythmias, cardiomyopathy), positive drug screen on admission for cocaine or amphetamines (to be performed per hospital policy and provider discretion), fetal malpresentation, hepatic impairment to include a known history of fatty liver disease, cirrhosis or previously documented abnormal liver function testing (AST >39, ALT >52) or lack of prenatal care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caffeine and sodium benzoate
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.
Drug: Caffeine and Sodium Benzoate Injection
Provide caffeine to shorten second stage of labor and augment pushing efforts
Placebo Comparator: Placebo
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.
Drug: Normal Saline
Provide normal saline to serve as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shortened second stage of labor
Time Frame: one year
Decrease in the length of the second stage of labor compared to the placebo group
one year
Reduction in maternal blood loss
Time Frame: one year
Decrease in quantitative blood loss in the intervention group compared to placebo
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of operative delivery
Time Frame: one year
Reduction in the incidence of operative delivery for maternal exhaustion in the intervention group
one year
Fetal APGAR score
Time Frame: one year
Evaluate improvements in fetal APGARs and incidence of apnea of prematurity
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Reading Hospital and Medical Center

Investigators

  • Principal Investigator: Daniel Jiang, MD, Reading Hospital Tower Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual data to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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