drugset / Trial / NCT05906303
Caffeine in the Second Stage of Labor in Low-risk Nulliparous Mothers at Term
RandomizedSingle-groupSingle-blindPrevention
Summary
Single blind, randomized control trial to determine benefit of caffeine and sodium benzoate on the second stage of labor
Timeline
- Start
- 2023-12-01
- Primary completion
- 2024-12-01
- Completion
- 2025-02-01
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 125 mg | Intravenous |
| Subject | Sodium Benzoate | Small molecule | 125 mg | Intravenous |
Indications
No indication recorded.