HyponatremiaNCT01708811
Hyponatremia and Myometrium Contractility. An Invitro Study
An observational study of Hyponatremia, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Hyponatremia
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Study population: Healthy women with singleton pregancies requiring delivery planned caesarean section.
Who may be able to join
- Singleton pregnancy at term
Who cannot join
- Preeclampsia
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Women and Child´s Health, Karolinska University Hospital, Solna
Stockholm, Stockholm County, 17176
About this study
Official title: 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.
Read the 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
- Conditions
- Hyponatremia
- Keywords
- Contractility, human, myometrium, hyponatraemia
- Medical subject headings
- Hyponatremia
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractility
Contractility will be measured, and data analyzed.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Few biopsies showed the expected pattern We suspect erroeneous method.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Moen, Karolinska Institutet
- Investigators
- Gunvor Ekman-Ordeberg, PhD, Principal investigator, Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708811
- Sponsor's protocol ID
- LOF-KS1
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19175600Kamizaki 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.
PubMed 3199594Sperelakis 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.
PubMed 1281264Cheek 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.
PubMed 8957980Garite 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.
PubMed 11120525
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Reduction in Plasma Sodium Reduce Myometrium Contractility in Humans? An Invitro Study of Pregnant Myometrium at Term.
- ClinicalTrials.gov ID
- NCT01708811
- Acronym / sponsor ID
- LOF-KS1
- Conditions
- Hyponatremia
- Keywords
- Contractility, human, myometrium, hyponatraemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Few biopsies showed the expected pattern We suspect erroeneous method.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy women with singleton pregancies requiring delivery planned caesarean section.
Key inclusion criteria (1 listed)
- Singleton pregnancy at term
Key exclusion criteria (1 listed)
- Preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contractility
Time frame: 24 hours
Contractility will be measured, and data analyzed.
Results and safety
The study was stopped early (reason given: Few biopsies showed the expected pattern We suspect erroeneous method.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 19175600Moen 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.
- Background: PubMed 3199594Kamizaki 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.
- Background: PubMed 1281264Sperelakis 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.
- Background: PubMed 8957980Cheek 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.
- Background: PubMed 11120525Garite 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunvor Ekman-Ordeberg, PhD principal investigator
Department of Women and Child´s Healt, karolinska University Hospital, Solna, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Few biopsies showed the expected pattern We suspect erroeneous method.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contractility (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708811, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.