Hyponatremia and Myometrium Contractility. An Invitro Study

This study is currently recruiting participants.
Verified November 2013 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01708811
First received: October 15, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

Hyponatremia during labour has been associated with prolonged labour, and increased incidence of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells are involved in contractility,and and influence of hyponatraemia on contractility can be suspected.


Condition
Hyponatremia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Contractility [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Contractility will be measured, and data analyzed.


Biospecimen Retention:   None Retained

Biopsies of pregant myometrium


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Biopsies will be obtained from pregnant women undergoing planned caesarean section at term. The biopsies will divided into 3 strips that will be stored overnight in chilled NaCl 0.9%. The following morning each strip will be mounted isometrically with one end fixed to a holder and the other end to a force transducer. One strip will be maintained in a solution containing 140mmol/L Na,acting as control, whereas the other two strips will be placed in fluids with diminishing Na concentration, from 140 mmol/L, to 130 mmol/L and 120 mmol/L. Contractility will be measured with force transducers and a polygraph

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Healthy women with singleton pregancies requiring delivery planned caesarean section.

Criteria

Inclusion Criteria:

  • Singleton pregnancy at term

Exclusion Criteria:

  • Preeclampsia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708811

Contacts
Contact: Gunvor Ekman Ordeberg, PhD +46851775366 gunvor.ekman-ordeberg@ki.se
Contact: Lars Irestedt, PhD 046851772341 lars.irestedt@karolinska.se

Locations
Sweden
Department of Women and Child´s Health, Karolinska University Hospital, Solna Recruiting
Stockholm, Sweden, 17176
Contact: Vibeke Moen, MD    +4648081200    vibekemoen@hotmail.com   
Principal Investigator: Gunvor Ekman-Ordeberg, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Gunvor Ekman-Ordeberg, PhD Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
  More Information

Publications:
Responsible Party: Vibeke Moen, research fellow, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01708811     History of Changes
Other Study ID Numbers: LOF-KS1
Study First Received: October 15, 2012
Last Updated: November 11, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska University Hospital:
Contractility
human
myometrium
hyponatraemia

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014