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Completed

NCT Number: NCT01242293

Intrapartum Hydration

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.

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Key information

Conditions

Labor Stage, First Labor Stage, Second Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dep OB/GYN, HaEmek Medical Center

Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.9% Saline with glucose 5%

Other

intravenous hydration at a rate of 125 ml per hour during labor

Ringer lactate

Other

intravenous hydration at a rate of 250 ml per hour during labor

Ringer lactate - Controls

Other

intravenous hydration at a rate of 125 ml per hour during labor

Primary outcomes

  1. Length of time from enrollment until delivery

    Time frame: within the first 48 hours after delivery

Secondary outcomes

  1. Mode of delivery

    Time frame: within the first 48 hours after delivery

  2. Neonatal outcome

    Time frame: within the first 48 hours after delivery

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2010
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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