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Hyponatremia and Myometrium Contractility. An Invitro Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708811
Recruitment Status : Terminated (Few biopsies showed the expected pattern We suspect erroeneous method.)
First Posted : October 17, 2012
Last Update Posted : October 14, 2015
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet

Brief Summary:
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 or disease

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

Study Type : Observational
Actual Enrollment : 12 participants
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.
Study Start Date : October 2012
Primary Completion Date : October 2015
Study Completion Date : October 2015

Primary Outcome Measures :
  1. Contractility [ Time Frame: 24 hours ]
    Contractility will be measured, and data analyzed.

Biospecimen Retention:   None Retained
Biopsies of pregant myometrium

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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