Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor
NCT ID: NCT07124130
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
158 participants
INTERVENTIONAL
2025-09-30
2026-03-31
Brief Summary
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1. Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers?
2. Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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5% dextrose and Lactate Ringer
Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor.
5% Dextrose (D5) in Normal Saline (NS)
A solution of 5% dextrose and lactate ringer will be given to one group of participants.
Lactate Ringer
A Lactate Ringer solution will be given to one group of participants.
Lactate Ringer only
Participants randomized to this arm will receive an intravenous Lactate Ringer solution only.
Lactate Ringer
A Lactate Ringer solution will be given to one group of participants.
Interventions
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5% Dextrose (D5) in Normal Saline (NS)
A solution of 5% dextrose and lactate ringer will be given to one group of participants.
Lactate Ringer
A Lactate Ringer solution will be given to one group of participants.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older and able to provide informed consent
* Singleton pregnancy at term
* Induction of labor
* Cephalic presentation
* Unfavorable cervix (Bishop score ≤ 6)
Exclusion Criteria
* Involuntarily confined or detained
* Considered as having diminished decision-making capacity
* Spontaneous labor (cervical exam between 5-6 cm) with or without ruptured membraned
* Favorable cervix (Bishop score \>6)
* Diabetes mellitus (both gestational and pre-gestational)
* Structural renal disease
* Acute or chronic kidney disease resulting in abnormal creatinine or proteinuria
* Evidence of chorioamnionitis or non-reassuring fetal testing at the time of enrollment
* Pyrexia (\>38.0 degrees Celsius)
* Stillbirth
* Planned cesarean delivery
* Women presenting with emergent circumstances for labor induction
18 Years
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia, Italy
UNKNOWN
Eastern Virginia Medical School
OTHER
Responsible Party
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Tetsuya Kawakita, MD
Associate Professor
Locations
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Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Policlinico di Modena
Modena, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Greenland S. Avoiding power loss associated with categorization and ordinal scores in dose-response and trend analysis. Epidemiology. 1995 Jul;6(4):450-4. doi: 10.1097/00001648-199507000-00025. No abstract available.
Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1045-52. doi: 10.3109/00016349.2010.499447.
Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6.
Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15.
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/
Shafaie FS, Mohaddesi H, Mirghafourvand M, Yulghunlu FA. A randomized, double-blinded, controlled trial comparing parenteral dextrose 5%, Ringer's solution and oral intake on the delivery outcomes in nulliparas. Int J Womens Health 2017;283-9.
Cowett RM, Susa JB, Giletti B, Oh W, Schwartz R. Glucose kinetics in infants of diabetic mothers. Am J Obstet Gynecol. 1983 Aug 1;146(7):781-6. doi: 10.1016/0002-9378(83)91077-3.
Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.
Cerri V, Tarantini M, Zuliani G, Schena V, Redaelli C, Nicolini U. Intravenous glucose infusion in labor does not affect maternal and fetal acid-base balance. J Matern Fetal Med. 2000 Jul-Aug;9(4):204-8. doi: 10.1002/1520-6661(200007/08)9:43.0.CO;2-9.
Fisher AJ, Huddleston JF. Intrapartum maternal glucose infusion reduces umbilical cord acidemia. Am J Obstet Gynecol. 1997 Oct;177(4):765-9. doi: 10.1016/s0002-9378(97)70265-5.
Pare J, Pasquier JC, Lewin A, Fraser W, Bureau YA. Reduction of total labor length through the addition of parenteral dextrose solution in induction of labor in nulliparous: results of DEXTRONS prospective randomized controlled trial. Am J Obstet Gynecol. 2017 May;216(5):508.e1-508.e7. doi: 10.1016/j.ajog.2017.01.010. Epub 2017 Jan 30.
Philipson EH, Kalhan SC, Riha MM, Pimentel R. Effects of maternal glucose infusion on fetal acid-base status in human pregnancy. Am J Obstet Gynecol. 1987 Oct;157(4 Pt 1):866-73. doi: 10.1016/s0002-9378(87)80075-3.
Collinot H, Merrer J, Girault A, Goffinet F, Le Ray C. Implementation of glucose 5% supplementation protocol to reduce the duration of labor among women with cervical ripening by prostaglandins: The GLUCOSHORT before-and-after study. J Gynecol Obstet Hum Reprod. 2023 May;52(5):102558. doi: 10.1016/j.jogoh.2023.102558. Epub 2023 Feb 19.
Sharma C, Kalra J, Bagga R, Kumar P. A randomized controlled trial comparing parenteral normal saline with and without 5% dextrose on the course of labor in nulliparous women. Arch Gynecol Obstet. 2012 Dec;286(6):1425-30. doi: 10.1007/s00404-012-2485-1. Epub 2012 Aug 4.
Shrivastava VK, Garite TJ, Jenkins SM, Saul L, Rumney P, Preslicka C, Chan K. A randomized, double-blinded, controlled trial comparing parenteral normal saline with and without dextrose on the course of labor in nulliparas. Am J Obstet Gynecol. 2009 Apr;200(4):379.e1-6. doi: 10.1016/j.ajog.2008.11.030. Epub 2009 Feb 14.
Hernandez Lopez AB, Muriel Miguel C, Fernandez-Canadas Morillo A, Lopez Lapeyrere C, Perez Medina T, Salcedo Marina A, Fornet Ruiz I, Rubio Gonzalez E, Solis Munoz M. Efficacy of "optimal hydration" during labor: HYDRATA study protocol for a randomized clinical trial. Res Nurs Health. 2020 Jan;43(1):8-16. doi: 10.1002/nur.21998. Epub 2019 Dec 2.
Nordstrom L, Arulkumaran S, Chua S, Ratnam S, Ingemarsson I, Kublickas M, Persson B, Shimojo N, Westgren M. Continuous maternal glucose infusion during labor: effects on maternal and fetal glucose and lactate levels. Am J Perinatol. 1995 Sep;12(5):357-62. doi: 10.1055/s-2007-994496.
Riegel M, Quist-Nelson J, Saccone G, Locci M, Shrivastava VK, Salim R, Fisher A, Nordstrom L, Kunselman AR, Repke J, Fong A, Smulian J, Xodo S, Mokhtari N, Zullo F, Berghella V. Dextrose intravenous fluid therapy in labor reduces the length of the first stage of labor. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:284-294. doi: 10.1016/j.ejogrb.2018.07.019. Epub 2018 Jul 17.
Stratton JF, Stronge J, Boylan PC. Hyponatraemia and non-electrolyte solutions in labouring primigravida. Eur J Obstet Gynecol Reprod Biol. 1995 Apr;59(2):149-51. doi: 10.1016/0028-2243(95)02042-q.
Oral E, Gezer A, Cagdas A, Pakkal N. Oxytocin infusion in labor: the effect different indications and the use of different diluents on neonatal bilirubin levels. Arch Gynecol Obstet. 2003 Jan;267(3):117-20. doi: 10.1007/s00404-002-0298-3.
Omigbodun AO, Akindele JA, Osotimehin BO, Fatinikun T, Fajimi JL, Adeleye JA. Effect of saline and glucose infusions of oxytocin on neonatal bilirubin levels. Int J Gynaecol Obstet. 1993 Mar;40(3):235-9. doi: 10.1016/0020-7292(93)90836-l.
Garmi G, Zuarez-Easton S, Zafran N, Ohel I, Berkovich I, Salim R. The effect of type and volume of fluid hydration on labor duration of nulliparous women: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jun;295(6):1407-1412. doi: 10.1007/s00404-017-4381-1. Epub 2017 May 3.
Loong EP, Lao TT, Chin RK. Effects of intrapartum intravenous infusion of 5% dextrose or Hartmann's solution on maternal and cord blood glucose. Acta Obstet Gynecol Scand. 1987;66(3):241-3. doi: 10.3109/00016348709020755.
Fong A, Serra AE, Caballero D, Garite TJ, Shrivastava VK. A randomized, double-blinded, controlled trial of the effects of fluid rate and/or presence of dextrose in intravenous fluids on the labor course of nulliparas. Am J Obstet Gynecol. 2017 Aug;217(2):208.e1-208.e7. doi: 10.1016/j.ajog.2017.03.010. Epub 2017 Mar 18.
Ahadi Yulghunlu F, Sehhatie Shafaie F, Mirghafourvand M, Mohaddesi H. The effects of intravenous dextrose 5%, Ringer's solution, and oral intake on the duration of labor stages in nulliparous women: a double-blind, randomized, controlled trial. J Matern Fetal Neonatal Med. 2020 Jan;33(2):289-296. doi: 10.1080/14767058.2018.1489792. Epub 2018 Sep 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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25-03-FB-0052
Identifier Type: -
Identifier Source: org_study_id
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