Hyponatremia and Myometrium Contractility. An Invitro Study | NCT01708811

Studies
Hyponatremia and Myometrium Contractility. An Invitro Study

NCT01708811

Sponsor

Karolinska University Hospital

Status

Terminated

Last Update Posted

Oct 14, 2015Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Hyponatremia

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Few biopsies showed the expected pattern We suspect erroeneous method.

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 16, 2012

First Posted Date

Oct 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contractility	Contractility will be measured, and data analyzed.	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton pregnancy at term

Exclusion Criteria:

Preeclampsia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

48 Years

Standard Ages

Adult

Study Population

Healthy women with singleton pregancies requiring delivery planned caesarean section.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunvor Ekman-Ordeberg, PhD	Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Women and Child´s Health, Karolinska University Hospital, Solna		Stockholm	Stockholm County	17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19175600	Background	Moen V, Brudin L, Rundgren M, Irestedt L. Hyponatremia complicating labour--rare or unrecognised? A prospective observational study. BJOG. 2009 Mar;116(4):552-61. doi: 10.1111/j.1471-0528.2008.02063.x. Epub 2009 Jan 27.
3199594	Background	Kamizaki J, Shimizu K, Nakajyo S, Urakawa N. A comparative study on the contraction induced by high K+/Na+ deficient solution in rat uterus or urinary bladder. Jpn J Pharmacol. 1988 Jun;47(2):179-88. doi: 10.1254/jjp.47.179.

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases