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

ConditionInduced Labor
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEastern Virginia Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Nulliparous women

Age 18 years or older and able to provide informed consent

Singleton pregnancy at term

Induction of labor

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5% Dextrose (D5) in Normal Saline (NS)

    Drug

    A solution of 5% dextrose and lactate ringer will be given to one group of participants.

  • Lactate Ringer

    Drug

    A Lactate Ringer solution will be given to one group of participants.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: 5% dextrose and Lactate RingerActive comparator 2 interventions
Group B: Lactate Ringer onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from Induction Start To Delivery

Time frame
From enrollment to the end of labor

Secondary outcomes

1

Type of amniotomy

Spontaneous vs artificial

Time frame
From enrollment until delivery
2

Mode of Delivery

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

Time frame
From enrollment until delivery.
3

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.
4

Delivery within 12 hours of induction.

Incidence of delivery within 12 hours of induction.

Time frame
Time from induction until delivery.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Virginia Medical School

Lead sponsor

University of Modena and Reggio Emilia

Collaborator

Source ClinicalTrials.gov
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