Clinical trial NCT01708811: Hyponatremia and Myometrium Contractility. An Invitro Study
Official title: Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyponatremia
Keywords: Contractility
human
myometrium
hyponatraemia
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women with singleton pregancies requiring delivery planned caesarean section.

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

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy at term

Exclusion Criteria:

* Preeclampsia

Primary outcomes:
measure: Contractility
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Women and Child´s Health, Karolinska University Hospital, Solna
Study officials:
affiliation: Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
name: Gunvor Ekman-Ordeberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1254/jjp.47.179.
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.
citation: 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. doi: 10.1093/bja/77.5.632.
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. doi: 10.1067/mob.2000.107884.