Hyponatremia and Myometrium Contractility. An Invitro Study

This study has been terminated.
(Few biopsies showed the expected pattern We suspect erroeneous method.)
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet
ClinicalTrials.gov Identifier:
First received: October 15, 2012
Last updated: October 12, 2015
Last verified: October 2015
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.


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

Enrollment: 12
Study Start Date: October 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (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

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.

Inclusion Criteria:

  • Singleton pregnancy at term

Exclusion Criteria:

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

Department of Women and Child´s Health, Karolinska University Hospital, Solna
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Principal Investigator: Gunvor Ekman-Ordeberg, PhD Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
  More Information

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: October 12, 2015
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska University Hospital:

Additional relevant MeSH terms:
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 27, 2015