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

NCT05906303 | Unknown Phase 1 FDA Drug

• 1 other identifier: 2022-113
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Second Stage of Labor

Outcome Measures

Primary Outcomes (2)

• Shortened second stage of labor

  Decrease in the length of the second stage of labor compared to the placebo group

  one year

• Reduction in maternal blood loss

  Decrease in quantitative blood loss in the intervention group compared to placebo

  one year

Secondary Outcomes (2)

• Incidence of operative delivery

  one year

• Fetal APGAR score

  one year

Study Arms (2)

Caffeine and sodium benzoate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Caffeine and Sodium Benzoate Injection DRUG

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

Caffeine and sodium benzoate

Normal Saline DRUG

Provide normal saline to serve as a placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Reading Hospital and Medical Center: lead

Study Sites (1)

Reading Hospital Labor & Delivery

West Reading, Pennsylvania, 19611, United States

Location

Related Publications (14)

• Headaches in Pregnancy and Postpartum: ACOG Clinical Practice Guideline No. 3. Obstet Gynecol. 2022 May 1;139(5):944-972. doi: 10.1097/AOG.0000000000004766.

  PMID: 35576364 BACKGROUND

• ACOG CommitteeOpinion No. 462: Moderate caffeine consumption during pregnancy. Obstet Gynecol. 2010 Aug;116(2 Pt 1):467-468. doi: 10.1097/AOG.0b013e3181eeb2a1.

  PMID: 20664420 BACKGROUND

• Wikoff D, Welsh BT, Henderson R, Brorby GP, Britt J, Myers E, Goldberger J, Lieberman HR, O'Brien C, Peck J, Tenenbein M, Weaver C, Harvey S, Urban J, Doepker C. Systematic review of the potential adverse effects of caffeine consumption in healthy adults, pregnant women, adolescents, and children. Food Chem Toxicol. 2017 Nov;109(Pt 1):585-648. doi: 10.1016/j.fct.2017.04.002. Epub 2017 Apr 21.

  PMID: 28438661 BACKGROUND

• Steinbrook RA, Garfield F, Batista SH, Urman RD. Caffeine for the prevention of postoperative nausea and vomiting. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):526-9. doi: 10.4103/0970-9185.119170.

  PMID: 24249992 BACKGROUND

• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: Final Data for 2017. Natl Vital Stat Rep. 2018 Nov;67(8):1-50.

  PMID: 30707672 BACKGROUND

• Yucel A, Ozyalcin S, Talu GK, Yucel EC, Erdine S. Intravenous administration of caffeine sodium benzoate for postdural puncture headache. Reg Anesth Pain Med. 1999 Jan-Feb;24(1):51-4.

  PMID: 9952095 BACKGROUND

• Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.

  PMID: 32217976 BACKGROUND

• Zhang J, Landy HJ, Ware Branch D, Burkman R, Haberman S, Gregory KD, Hatjis CG, Ramirez MM, Bailit JL, Gonzalez-Quintero VH, Hibbard JU, Hoffman MK, Kominiarek M, Learman LA, Van Veldhuisen P, Troendle J, Reddy UM; Consortium on Safe Labor. Contemporary patterns of spontaneous labor with normal neonatal outcomes. Obstet Gynecol. 2010 Dec;116(6):1281-1287. doi: 10.1097/AOG.0b013e3181fdef6e.

  PMID: 21099592 BACKGROUND

• Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med. 2005 Sep;18(3):149-54. doi: 10.1080/14767050500170088.

  PMID: 16272036 BACKGROUND

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• Southward K, Rutherfurd-Markwick KJ, Ali A. The Effect of Acute Caffeine Ingestion on Endurance Performance: A Systematic Review and Meta-Analysis. Sports Med. 2018 Aug;48(8):1913-1928. doi: 10.1007/s40279-018-0939-8.

  PMID: 29876876 BACKGROUND

• Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4.

  PMID: 33388079 BACKGROUND

• Song YJ, Kristal AR, Wicklund KG, Cushing-Haugen KL, Rossing MA. Coffee, tea, colas, and risk of epithelial ovarian cancer. Cancer Epidemiol Biomarkers Prev. 2008 Mar;17(3):712-6. doi: 10.1158/1055-9965.EPI-07-2511.

  PMID: 18349292 BACKGROUND

• Rosenbloom JI, Rottenstreich A, Yagel S, Sompolinksy Y, Levin G. The length of the second stage of labor in nulliparous, multiparous, grand-multiparous, and grand-grand multiparous women in a large modern cohort. Eur J Obstet Gynecol Reprod Biol. 2020 Oct;253:273-277. doi: 10.1016/j.ejogrb.2020.08.029. Epub 2020 Aug 23.

  PMID: 32898773 BACKGROUND

MeSH Terms

Interventions

caffeine, sodium benzoate drug combination; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Daniel Jiang, MD

  Reading Hospital Tower Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Jiang, MD

CONTACT

4846288981; daniel.jiang@towerhealth.org

Angel Marquez, DO

CONTACT

5612511451; angel.marquez@towerhealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will receive either a mixture of caffeine and sodium benzoate dissolved in 500 cc normal saline or normal saline alone. A randomization schedule held by the OB team to determine which arm the patient falls into. The product will be prepared by pharmacy and sent to the labor floor. The infusion will be started once the patient is determined to be 10 cm in cervical dilation without notice to the patient.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Blind, Randomized control trial

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: September 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)