Hyponatremia and Myometrium Contractility. An Invitro Study

This study has been terminated.
(Few biopsies showed the expected pattern We suspect erroeneous method.)
Sponsor:
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01708811
First received: October 15, 2012
Last updated: October 12, 2015
Last verified: October 2015

October 15, 2012
October 12, 2015
October 2012
October 2015   (final data collection date for primary outcome measure)
Contractility [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Contractility will be measured, and data analyzed.
Same as current
Complete list of historical versions of study NCT01708811 on ClinicalTrials.gov Archive Site
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Hyponatremia and Myometrium Contractility. An Invitro Study
Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.
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.
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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
Biopsies of pregant myometrium
Non-Probability Sample
Healthy women with singleton pregancies requiring delivery planned caesarean section.
Hyponatremia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Singleton pregnancy at term

Exclusion Criteria:

  • Preeclampsia
Female
18 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01708811
LOF-KS1
No
Not Provided
Not Provided
Vibeke Moen, Karolinska Institutet
Karolinska University Hospital
Not Provided
Principal Investigator: Gunvor Ekman-Ordeberg, PhD Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
Karolinska University Hospital
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP