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Recruiting NCT07124130

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

Phase IV Interventional Induced Labor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5% Dextrose (D5) in Normal Saline (NS), Lactate Ringer.
Who it may be relevant to
Registry conditions: Induced Labor. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sentara Norfolk General Hospital — Norfolk
Italy · 1 center
  • Policlinico di Modena — Modena

Publications

  • 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.

Identifiers

NCT: NCT07124130 · 25-03-FB-0052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗