Intrapartum Hydration

Labor Stage, First Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242293
• Other study ID #: 0062-10-EMC
• Secondary ID: IH-1
• Status: Completed
• Phase: N/A
• First received: November 15, 2010
• Last updated: February 20, 2016
• Start date: November 2010
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Stage, First
• Labor Stage, Second

Intervention

Other:
• 0.9% Saline with glucose 5%
intravenous hydration at a rate of 125 ml per hour during labor
• Ringer lactate
intravenous hydration at a rate of 250 ml per hour during labor
• Ringer lactate - Controls
intravenous hydration at a rate of 125 ml per hour during labor

Locations

Country	Name	City	State
Israel	Dep OB/GYN, HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time from enrollment until delivery		within the first 48 hours after delivery	No
Secondary	Mode of delivery		within the first 48 hours after delivery	No
Secondary	Neonatal outcome		within the first 48 hours after delivery	Yes