Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hyponatremia and Myometrium Contractility. An Invitro Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Karolinska University Hospital
Information provided by (Responsible Party):
Vibeke Moen, Karolinska Institutet Identifier:
First received: October 15, 2012
Last updated: November 11, 2013
Last verified: November 2013

October 15, 2012
November 11, 2013
October 2012
March 2014   (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 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 Model: Case-Only
Time Perspective: Prospective
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Retention:   None Retained

Biopsies of pregant myometrium

Non-Probability Sample

Healthy women with singleton pregancies requiring delivery planned caesarean section.

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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Singleton pregnancy at term

Exclusion Criteria:

  • Preeclampsia
18 Years to 48 Years
Contact: Gunvor Ekman Ordeberg, PhD +46851775366
Contact: Lars Irestedt, PhD 046851772341
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
November 2013

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