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

NCT ID: NCT05906303

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-02-01

Brief Summary

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

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.

Conditions

Second Stage of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Caffeine and Sodium Benzoate Injection

Intervention Type: DRUG

Provide caffeine to shorten second stage of labor and augment pushing efforts

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Provide normal saline to serve as a placebo

Interventions

Caffeine and Sodium Benzoate Injection

Provide caffeine to shorten second stage of labor and augment pushing efforts

Intervention Type: DRUG

Normal Saline

Provide normal saline to serve as a placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Reading Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Reading Hospital Tower Health

Locations

Reading Hospital Labor & Delivery

West Reading, Pennsylvania, United States

Countries

United States

Central Contacts

Daniel Jiang, MD

Role: CONTACT

daniel.jiang@towerhealth.org

4846288981

Angel Marquez, DO

Role: CONTACT

angel.marquez@towerhealth.org

5612511451

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Other Identifiers

2022-113

Identifier Type: -

Identifier Source: org_study_id