Intrapartum Hydration

NCT ID: NCT01242293

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Labor Stage, First Labor Stage, Second

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.9% Saline with glucose 5%

rate of infusion is 125cc/h

Group Type ACTIVE_COMPARATOR

0.9% Saline with glucose 5%

Intervention Type OTHER

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

Ringer lactate

rate of infusion is 250cc/h

Group Type ACTIVE_COMPARATOR

Ringer lactate

Intervention Type OTHER

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

Ringer lactate - Controls

rate of infusion is 125cc/h

Group Type ACTIVE_COMPARATOR

Ringer lactate - Controls

Intervention Type OTHER

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

Interventions

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0.9% Saline with glucose 5%

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

Intervention Type OTHER

Ringer lactate

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

Intervention Type OTHER

Ringer lactate - Controls

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Raed Salim

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raed Salim, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. OB/GYN, HaEmek Medical Center, Afula, Israel

Locations

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Dep OB/GYN, HaEmek Medical Center

Afula, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 28470550 (View on PubMed)

Other Identifiers

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IH-1

Identifier Type: OTHER

Identifier Source: secondary_id

0062-10-EMC

Identifier Type: -

Identifier Source: org_study_id

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