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Trial registered on ANZCTR


Registration number
ACTRN12612000517875
Ethics application status
Approved
Date submitted
23/04/2012
Date registered
15/05/2012
Date last updated
15/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hypotension in Threatened Preterm Labour Treating with Initial Loading Dose of 30 mg versus 40 mg Nifedipine
Scientific title
Hypotension in Threatened Preterm Labour Treating with Initial Loading Dose of 30 mg versus 40 mg Nifedipine
Secondary ID [1] 280363 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension in threatened preterm pregnant who treated with nifedipine 286336 0
Condition category
Condition code
Reproductive Health and Childbirth 286580 286580 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 286702 286702 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: nifedipine 30 mg loading in 1 hour (10 mg orally every 20 minutes) then nifedipine slow release (SR) 20 mg orally every 4-8 hours until 48 hours, regularly of treatment given will be at the discretion of the treating physician
Intervention code [1] 284729 0
Treatment: Drugs
Comparator / control treatment
Arm 2: nifedipine 40 mg loading in 1 hour (10 mg orally every 15 minutes) then nifedipine slow release (SR) 20 mg orally every 4-8 hours until 48 hours, regularly of treatment given will be at the discretion of the treating physician
Control group
Dose comparison

Outcomes
Primary outcome [1] 287001 0
Incidence of hypotension measurement by non invasive measurement instrument,autonomic blood pressure monitor,Dinamap blood pressure monitor have set the standard for accuracy and have been calibrated by schedule and all candidate will use the same instrument and systolic and diastolic blood pressure were recorded in medical recording form.
Timepoint [1] 287001 0
At 48 hours after drug administration
Secondary outcome [1] 297178 0
Nil
Timepoint [1] 297178 0
Nil

Eligibility
Key inclusion criteria
Pregnant women with gestational age between 24 to 36 weeks with one or more uterine contractions in 10 minutes with Cervical dilatation 0 to 3 cm
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.History of active medical diseases: e.g. cardiovascular diseases, renal diseases, diabetes, hyperthyroidism, infection

2.Pregnant women with contra-indication for inhibiting preterm labor e.g. chorioamnionitis, placental abruption, ruptured vasa previa, uterine rupture, severe preeclampsia, eclampsia, severe fetal anomalies, rupture of membrane, and etc.

3.Contra-indication for oral route treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque-sealed envelops will be used for treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use computer-generated random sequence with varying block size randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 4273 0
Thailand
State/province [1] 4273 0
Khon Kaen

Funding & Sponsors
Funding source category [1] 285138 0
Hospital
Name [1] 285138 0
Khon Kaen Hospital
Country [1] 285138 0
Thailand
Primary sponsor type
Hospital
Name
Khon Kaen Hospital
Address
Srichan road
Muang
Khon Kaen
40000
Country
Thailand
Secondary sponsor category [1] 284007 0
Individual
Name [1] 284007 0
Ananya Somsaard
Address [1] 284007 0
Srichan road
Muang
Khon Kaen
40000
Country [1] 284007 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287158 0
Khon Kaen Hospital Ethics Committee
Ethics committee address [1] 287158 0
Srichan road
Muang
Khon Kaen
40000
Ethics committee country [1] 287158 0
Thailand
Date submitted for ethics approval [1] 287158 0
01/09/2011
Approval date [1] 287158 0
28/09/2011
Ethics approval number [1] 287158 0
59/01/2554

Summary
Brief summary
Preterm birth significantly contributes to infant morbidities and neurological disability. It has been hope that tocolytic treatment would reduce the consequences of preterm birth by prolonging pregnancy
Calcium channel blockers (CCB) have been used to prevent preterm labor over 20 years. Nifedipine is the first CCB used for tocolytics therapy by 1980
Although nifedipine has significantly lower of maternal and fetal side-effects than alternatives, but the major concern is about vasodilating properties which can induce maternal tachycardia, headache, nausea, hot flush, palpitation and especially severe hypotension
Suchaya 2010 study in 157 Thai women 17% of cases experienced hypotension within 60 min after receiving nifedipine. Of these there was no severe hypotension. But if the pregnant women had lower baseline, profound shock can be occurred (Before using nifedipine, the mean systolic and diastolic blood pressures were 109.4 +/- 10.4 and 72.5 +/- 7.9 mmHg the mean decrease of systolic and diastolic blood pressure in severe hypotension was 16.3 and 14.5 mmHg) The incidence of profound hypotension(BP<90/60 mmHg) at first 60 minutes is 3.8%
From previous study show that there was same effectiveness of using oral nifedipine 30 mg between 40 mg loading in the first hour for tocolysis .In Suchaya 2010 trial was study in Thai pregnant woman show incidence of hypotension was 17% when treated preterm labour with initial loading dose 40 mg . We aim that decreasing the incidence of hypotension could be reached by lowering the initial nifedipine loading dose
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34092 0
Address 34092 0
Country 34092 0
Phone 34092 0
Fax 34092 0
Email 34092 0
Contact person for public queries
Name 17339 0
Thirawut Khanprakob
Address 17339 0
Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
Country 17339 0
Thailand
Phone 17339 0
+66883394554
Fax 17339 0
+6643336789 ext 3736
Email 17339 0
[email protected]
Contact person for scientific queries
Name 8267 0
Thirawut Khanprakob
Address 8267 0
Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000
Country 8267 0
Thailand
Phone 8267 0
+66883394554
Fax 8267 0
+6643336789 ext 3736
Email 8267 0
[email protected]

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