Intrapartum Hydration

Study Overview
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Brief Summary
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The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.

Detailed Description
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During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.

Conditions
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Labor Stage, First, Labor Stage, Second

Intervention / Treatment
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* Other: 0.9% Saline with glucose 5%
* Other: Ringer lactate
* Other: Ringer lactate - Controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women Gestational age 37-41 weeks Cervical dilatation 1-3 cm Vertex presentation Singleton Exclusion Criteria: Diabetes Preeclampsia Intra uterine fetal growth restriction Duration of labor less than an hour Maternal chronic disease Maternal fever upon admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.9% Saline with glucose 5%<br>rate of infusion is 125cc/h | Other: 0.9% Saline with glucose 5%<br>* intravenous hydration at a rate of 125 ml per hour during labor<br>|
| Active Comparator: Ringer lactate<br>rate of infusion is 250cc/h | Other: Ringer lactate<br>* intravenous hydration at a rate of 250 ml per hour during labor<br>|
| Active Comparator: Ringer lactate - Controls<br>rate of infusion is 125cc/h | Other: Ringer lactate - Controls<br>* intravenous hydration at a rate of 125 ml per hour during labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time from enrollment until delivery |  | within the first 48 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery |  | within the first 48 hours after delivery | 
| Neonatal outcome |  | within the first 48 hours after delivery |