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Intrapartum Hydration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242293
First Posted: November 17, 2010
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
  Purpose
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.

Condition Intervention
Labor Stage, First Labor Stage, Second Other: 0.9% Saline with glucose 5% Other: Ringer lactate Other: Ringer lactate - Controls

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

Resource links provided by NLM:


Further study details as provided by Raed Salim, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Length of time from enrollment until delivery [ Time Frame: within the first 48 hours after delivery ]

Secondary Outcome Measures:
  • Mode of delivery [ Time Frame: within the first 48 hours after delivery ]
  • Neonatal outcome [ Time Frame: within the first 48 hours after delivery ]

Enrollment: 300
Study Start Date: November 2010
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.9% Saline with glucose 5%
rate of infusion is 125cc/h
Other: 0.9% Saline with glucose 5%
intravenous hydration at a rate of 125 ml per hour during labor
Active Comparator: Ringer lactate
rate of infusion is 250cc/h
Other: Ringer lactate
intravenous hydration at a rate of 250 ml per hour during labor
Active Comparator: Ringer lactate - Controls
rate of infusion is 125cc/h
Other: Ringer lactate - Controls
intravenous hydration at a rate of 125 ml per hour during labor

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242293


Locations
Israel
Dep OB/GYN, HaEmek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim, MD Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
  More Information

Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01242293     History of Changes
Other Study ID Numbers: 0062-10-EMC
IH-1 ( Other Identifier: 0062-10-EMC )
First Submitted: November 15, 2010
First Posted: November 17, 2010
Last Update Posted: February 23, 2016
Last Verified: February 2016