Study Stopped
Few biopsies showed the expected pattern We suspect erroeneous method.
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.
1 other identifier
observational
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 14, 2015
October 1, 2015
3 years
October 15, 2012
October 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contractility
Contractility will be measured, and data analyzed.
24 hours
Eligibility Criteria
Healthy women with singleton pregancies requiring delivery planned caesarean section.
You may qualify if:
- Singleton pregnancy at term
You may not qualify if:
- Preeclampsia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Women and Child´s Health, Karolinska University Hospital, Solna
Stockholm, Stockholm County, 17176, Sweden
Related Publications (5)
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.
PMID: 19175600BACKGROUNDKamizaki 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.
PMID: 3199594BACKGROUNDSperelakis 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.
PMID: 1281264BACKGROUNDCheek 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.
PMID: 8957980BACKGROUNDGarite 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.
PMID: 11120525BACKGROUND
Biospecimen
Biopsies of pregant myometrium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gunvor Ekman-Ordeberg, PhD
Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research fellow
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 17, 2012
Study Start
October 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 14, 2015
Record last verified: 2015-10