Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000241639
Ethics application status
Approved
Date submitted
28/02/2014
Date registered
6/03/2014
Date last updated
6/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal cardiovascular indices in early pregnancy
Scientific title
A study comparing maternal cardiovascular indices of women with healthy early pregnancies (<12 weeks gestation) and those with spontaneous fetal demise.
Secondary ID [1] 284178 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy early pregnancy 291276 0
Spontaneous miscarriages in early pregnancy 291277 0
Condition category
Condition code
Reproductive Health and Childbirth 291630 291630 0 0
Normal pregnancy
Reproductive Health and Childbirth 291631 291631 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Maternal cardiovascular indices eg. cardiac output (CO)and systemic vascular resistances (SVR)of 20 women with spontaneous miscarriages <12 weeks,will be recorded non-invasively using a continuous wave Doppler ultrasound probe placed at the suprasternal notch to insonate the velocity of blood flow through the aortic valve, using the USCOM cardiac output monitor (USCOM Ltd. Sydney, Australia). This will take approximately 1 minute.
Intervention code [1] 288877 0
Not applicable
Comparator / control treatment
The comparator group will comprise 20 women with healthy early pregnancies (between 8-11 gestational weeks), in whom their maternal cardiovascular indices will be similarly recorded with the USCOM cardiac output monitor.
Control group
Active

Outcomes
Primary outcome [1] 291561 0
The primary outcome of interest is systemic vascular resistance (SVR), which is measured non-invasively with the USCOM monitor.
Timepoint [1] 291561 0
This will be measured non-invasively with the USCOM monitor in the operating theatres, prior to the patient presenting for elective termination of pregnancies or their surgical uterine currettage (in those with spontaneous miscarriages scheduled for evacuation of uterus).
Secondary outcome [1] 307078 0
nil
Timepoint [1] 307078 0
nil

Eligibility
Key inclusion criteria
Twenty ASA I- II patients scheduled for elective pregnancy terminations between 8-11 gestational weeks, and 20 women with spontaneous miscarriages of <12 weeks' gestation who are scheduled for surgical uterine evacuation.
Minimum age
21 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA physical status III- IV, BMI > 40 kg/m2, aged <21 or > 50years, and those with significant pre-existing cardiovascular disease pre-pregnancy eg hypertension, ischaemic heart disease, valvular heart disease, cardiomyopathy.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size was based on Lo Presti’s study (Lo Presti et al., Pregnancy Hypertension 2013) that found a mean (SD) SVR of 1400 (300) dyne.sec-1cm-5 in women who had spontaneous abortions compared to those with normal healthy early pregnancies. Prospective power analysis showed that a sample size of 18 patients per group would be required to detect a 20% difference in the primary outcome at a significance level of 5% and power of 80%. We will therefore recruit 20 patients to account for drop-outs.Data will be analysed using SPSS version 20.0. The following tests will be used to compare data between the two groups: Student’s t-test for patient demographics and other parametric data; Mann-Whitney U-test for non-parametric data; Fisher’s exact test for proportions. p<0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2014
Actual
Date of last participant enrolment
Anticipated
2/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5855 0
Singapore
State/province [1] 5855 0

Funding & Sponsors
Funding source category [1] 288805 0
Self funded/Unfunded
Name [1] 288805 0
Country [1] 288805 0
Primary sponsor type
Individual
Name
Dr Wendy H.L. Teoh
Address
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country
Singapore
Secondary sponsor category [1] 287501 0
None
Name [1] 287501 0
Address [1] 287501 0
Country [1] 287501 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290651 0
Singhealth Centralised Institutional Review Board D
Ethics committee address [1] 290651 0
Singapore Health Services Pte.Ltd,
31 Third Hospital Avenue,
#03-03 Bowyer Block C,
Singapore 168753.
Ethics committee country [1] 290651 0
Singapore
Date submitted for ethics approval [1] 290651 0
18/02/2014
Approval date [1] 290651 0
21/02/2014
Ethics approval number [1] 290651 0
CIRB 2014/068/D

Summary
Brief summary
The aim of this observational prospective cohort study is to compare maternal cardiovascular indices of 20 women with healthy early pregnancies (8-11 weeks gestation) with that of 20 women who have experienced spontaneous miscarriages, to see if there is a difference in systemic vascular resistances (SVR) [the primary outcome of interest]. This information will help in our understanding of a subset of women’s possible causes for miscarriages in early pregnancy, as prior research indicates that some women may have higher SVR and abnormal adaptations to normal pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46606 0
Dr Wendy H.L Teoh
Address 46606 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country 46606 0
Singapore
Phone 46606 0
+65- 63941081
Fax 46606 0
+65- 62912661
Email 46606 0
[email protected]
Contact person for public queries
Name 46607 0
Wendy H.L Teoh
Address 46607 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country 46607 0
Singapore
Phone 46607 0
+65- 63941081
Fax 46607 0
Email 46607 0
[email protected]
Contact person for scientific queries
Name 46608 0
Wendy H.L Teoh
Address 46608 0
Department of Women’s Anaesthesia,
KK Women’s and Children’s Hospital,
100 Bukit Timah Road
Singapore 229899
Country 46608 0
Singapore
Phone 46608 0
+65- 63941081
Fax 46608 0
Email 46608 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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