Intrapartum Hydration
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFebruary 23, 2016
February 1, 2016
4.7 years
November 15, 2010
February 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Length of time from enrollment until delivery
within the first 48 hours after delivery
Secondary Outcomes (2)
Mode of delivery
within the first 48 hours after delivery
Neonatal outcome
within the first 48 hours after delivery
Study Arms (3)
0.9% Saline with glucose 5%
ACTIVE COMPARATORrate of infusion is 125cc/h
Ringer lactate
ACTIVE COMPARATORrate of infusion is 250cc/h
Ringer lactate - Controls
ACTIVE COMPARATORrate of infusion is 125cc/h
Interventions
intravenous hydration at a rate of 125 ml per hour during labor
intravenous hydration at a rate of 125 ml per hour during labor
Eligibility Criteria
You may qualify if:
- Nulliparous women
- Gestational age 37-41 weeks
- Cervical dilatation 1-3 cm
- Vertex presentation
- Singleton
You may not qualify if:
- Diabetes
- Preeclampsia
- Intra uterine fetal growth restriction
- Duration of labor less than an hour
- Maternal chronic disease
- Maternal fever upon admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dep OB/GYN, HaEmek Medical Center
Afula, Israel
Related Publications (1)
Garmi G, Zuarez-Easton S, Zafran N, Ohel I, Berkovich I, Salim R. The effect of type and volume of fluid hydration on labor duration of nulliparous women: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jun;295(6):1407-1412. doi: 10.1007/s00404-017-4381-1. Epub 2017 May 3.
PMID: 28470550DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raed Salim, MD
Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 17, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
February 23, 2016
Record last verified: 2016-02