ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Cardiovascular

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]

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]

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]

At 48 hours after drug administration

Secondary outcome [1]

Nil

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Thailand

State/province [1]

Khon Kaen

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Khon Kaen Hospital

Address [1]

Srichan road
Muang
Khon Kaen
40000

Country [1]

Thailand

Primary sponsor type

Hospital

Name

Khon Kaen Hospital

Address

Srichan road
Muang
Khon Kaen
40000

Country

Thailand

Secondary sponsor category [1]

Individual

Name [1]

Ananya Somsaard

Address [1]

Srichan road
Muang
Khon Kaen
40000

Country [1]

Thailand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Khon Kaen Hospital Ethics Committee

Ethics committee address [1]

Srichan road
Muang
Khon Kaen 
40000

Ethics committee country [1]

Thailand

Date submitted for ethics approval [1]

01/09/2011

Approval date [1]

28/09/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Thirawut Khanprakob

Address

Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000

Country

Thailand

Phone

+66883394554

Fax

+6643336789 ext 3736

thirawut_k@hotmail.com

Contact person for scientific queries

Name

Thirawut Khanprakob

Address

Khon Kaen Hospital
Srichan Road
Muang
Khon Kaen
40000

Country

Thailand

Phone

+66883394554

Fax

+6643336789 ext 3736

thirawut_k@hotmail.com

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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