A Phase 1 interventional study of Caffeine and Sodium Benzoate Injection and Normal Saline in Second Stage of Labor, sponsored by The Reading Hospital and Medical Center. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by The Reading Hospital and Medical Center · Phase 1, Interventional, and Prevention
Single blind, randomized control trial to determine benefit of caffeine and sodium benzoate on the second stage of labor
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.
The Reading Hospital and Medical Center is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: Caffeine · Sodium Benzoate
Provide caffeine to shorten second stage of labor and augment pushing efforts
Provide normal saline to serve as a placebo
Shortened second stage of labor
Decrease in the length of the second stage of labor compared to the placebo group
Time frame: one year
Reduction in maternal blood loss
Decrease in quantitative blood loss in the intervention group compared to placebo
Time frame: one year
Incidence of operative delivery
Reduction in the incidence of operative delivery for maternal exhaustion in the intervention group
Time frame: one year
Fetal APGAR score
Evaluate improvements in fetal APGARs and incidence of apnea of prematurity
Time frame: one year
Plan to share: No — No individual data to be shared
Start is estimated for Dec 2023; primary completion for Dec 2024, 12 months later.
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This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Caffeine · Sodium Benzoate
The Reading Hospital and Medical Center