Intrapartum Hydration

Not Applicable

Completed

• Conditions: Labor Stage, First; Labor Stage, Second
• Interventions: Other: Ringer lactate; Other: 0.9% Saline with glucose 5%; Other: Ringer lactate - Controls

• Registration Number: NCT01242293
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-17
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-20
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer lactate	Ringer lactate	rate of infusion is 250cc/h
0.9% Saline with glucose 5%	0.9% Saline with glucose 5%	rate of infusion is 125cc/h
Ringer lactate - Controls	Ringer lactate - Controls	rate of infusion is 125cc/h

Primary Outcome Measures

Name	Time	Method
Length of time from enrollment until delivery	within the first 48 hours after delivery

Secondary Outcome Measures

Name	Time	Method
Mode of delivery	within the first 48 hours after delivery
Neonatal outcome	within the first 48 hours after delivery

Trial Locations

Locations (1)

Dep OB/GYN, HaEmek Medical Center; 🇮🇱 Afula, Israel