Intrapartum Hydration

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01242293
First received: November 15, 2010
Last updated: April 8, 2014
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Length of time from enrollment until delivery [ Time Frame: within the first 48 hours after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mode of delivery [ Time Frame: within the first 48 hours after delivery ] [ Designated as safety issue: No ]
  • Neonatal outcome [ Time Frame: within the first 48 hours after delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242293

Contacts
Contact: Raed Salim, MD 97246494031 salim_ra@clalit.org.il

Locations
Israel
Dep OB/GYN, HaEmek Medical Center Recruiting
Afula, Israel
Contact: Raed Salim, MD       salim_ra@clalit.org.il   
Principal Investigator: Raed Salim, MD         
Sub-Investigator: Iris Ohel, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Raed Salim, MD Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
  More Information

No publications provided

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
Study First Received: November 15, 2010
Last Updated: April 8, 2014
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on October 21, 2014