Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor

Официальное название

Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes

Обзор

The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are: 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.

Вмешательства

• Препарат 5% Dextrose (D5) in Normal Saline (NS)
  A solution of 5% dextrose and lactate ringer will be given to one group of participants.
• Препарат Lactate Ringer
  A Lactate Ringer solution will be given to one group of participants.

Первичные конечные точки

• Time from Induction Start To Delivery [Срок оценки: From enrollment to the end of labor]

Вторичные конечные точки (12)

• Type of amniotomy [Срок оценки: From enrollment until delivery]
• Mode of Delivery [Срок оценки: From enrollment until delivery.]
• Indication for cesarean delivery [Срок оценки: From enrollment until delivery.]
• Delivery within 12 hours of induction. [Срок оценки: Time from induction until delivery.]
• Delivery within 24 hours of Induction [Срок оценки: Time of induction to time of delivery.]
• Delivery within 36 hours of Induction [Срок оценки: From time of induction to time of delivery.]
• Delivery within 48 hours of Induction [Срок оценки: From time of induction to time of delivery.]
• Perineal Lacerations (Degree I-IV) [Срок оценки: From time of enrollment to time of delivery.]
• Postpartum hemorrhage [Срок оценки: Time of enrollment to time of delivery.]
• Blood Transfusion [Срок оценки: From time of enrollment to hospital discharge (up to 42 days post-delivery).]
• Isolated maternal fever [Срок оценки: From time of enrollment to hospital discharge (up to 42 days post-delivery).]
• Diagnosed Endometritis [Срок оценки: From time of enrollment to hospital discharge (up to 42 days post-delivery).]

Критерии участия

Критерии включения

• Nulliparous women
• 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)

Критерии исключения

• Age under 18 years
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sentara Norfolk General Hospital — Norfolk

Италия · 1 центр

• Policlinico di Modena — Modena

Публикации

• 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. PMID 7548361
• 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. PMID 23303106
• 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. PMID 20636243
• 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. PMID 35135684
• 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. PMID 38367749
• 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. PMID 20332509
• WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/ PMID 30070803
• 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.

Идентификаторы

NCT: NCT07124130 · 25-03-FB-0052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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