Hyponatremia and Myometrium Contractility. An Invitro Study

Hyponatremia Clinical Trial

Official title:

Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01708811
• Other study ID #: LOF-KS1
• Status: Terminated
• Phase: N/A
• First received: October 15, 2012
• Last updated: October 12, 2015
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy at term

Exclusion Criteria:

• Preeclampsia

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyponatremia

Locations

Country	Name	City	State
Sweden	Department of Women and Child´s Health, Karolinska University Hospital, Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Cheek TG, Samuels P, Miller F, Tobin M, Gutsche BB. Normal saline i.v. fluid load decreases uterine activity in active labour. Br J Anaesth. 1996 Nov;77(5):632-5. — View Citation

Garite TJ, Weeks J, Peters-Phair K, Pattillo C, Brewster WR. A randomized controlled trial of the effect of increased intravenous hydration on the course of labor in nulliparous women. Am J Obstet Gynecol. 2000 Dec;183(6):1544-8. — View Citation

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. — View Citation

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. — View Citation

Sperelakis N, Inoue Y, Ohya Y. Fast Na+ channels and slow Ca2+ current in smooth muscle from pregnant rat uterus. Mol Cell Biochem. 1992 Sep 8;114(1-2):79-89. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contractility	Contractility will be measured, and data analyzed.	24 hours	No