Intrapartum Hydration

HaEmek Medical Center, Israel

Status: Completed

Conditions: Labor Stage, Second; Labor Stage, First

Treatments: Other: Ringer lactate - Controls; Other: Ringer lactate; Other: 0.9% Saline with glucose 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01242293

IH-1 (Other Identifier)

0062-10-EMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

0.9% Saline with glucose 5%

Active Comparator group

Description:

rate of infusion is 125cc/h

Treatment:

Other: 0.9% Saline with glucose 5%

Ringer lactate

Active Comparator group

Description:

rate of infusion is 250cc/h

Treatment:

Other: Ringer lactate

Ringer lactate - Controls

Active Comparator group

Description:

rate of infusion is 125cc/h

Treatment:

Other: Ringer lactate - Controls