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Hypotension in Threatened Preterm Labour Treating with Initial Loading Dose of 30 mg versus 40 mg Nifedipine

Hypotension in Threatened Preterm Labour Treating with Initial Loading Dose of 30 mg versus 40 mg Nifedipine

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000517875
Acronym
nil
Enrollment
90
Registered
2012-05-15
Start date
2012-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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

Sponsors

Khon Kaen Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026