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

Phase 4RecruitingNCT07124130

Eastern Virginia Medical School158 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

158

Conditions

Induced Labor

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

RECRUITING

Policlinico di Modena

Modena, Italy

RECRUITING

Outcomes

Primary Outcomes

Time from Induction Start To Delivery

Time frame: From enrollment to the end of labor

Secondary Outcomes

Type of amniotomy

Spontaneous vs artificial

Time frame: From enrollment until delivery

Mode of Delivery

The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery.

Time frame: From enrollment until delivery.

Indication for cesarean delivery

Rate of failed induction of labor, arrest of active phase, arrest of descent, non-reassuring fetal condition, maternal request, other.

Time frame: From enrollment until delivery.

Delivery within 12 hours of induction.

Incidence of delivery within 12 hours of induction.

Time frame: Time from induction until delivery.

Delivery within 24 hours of Induction

Incidence of delivery within 24 hours of induction.

Time frame: Time of induction to time of delivery.

Delivery within 36 hours of Induction

Incidence of delivery within 36 hours of induction.

Time frame: From time of induction to time of delivery.

Delivery within 48 hours of Induction

Incidence of delivery within 48 hours of induction.

Time frame: From time of induction to time of delivery.

Perineal Lacerations (Degree I-IV)

Degree of perineal lacerations occurring during delivery (first to fourth degree).

Time frame: From time of enrollment to time of delivery.

Postpartum hemorrhage

Blood loss \>1000 mL

Time frame: Time of enrollment to time of delivery.

Blood Transfusion

Incidence of blood transfusions required during or after delivery.