A Phase 2 interventional study of utrogestan and Nifedipine in Preterm Labor, sponsored by nor zila hassan malek. Status unknown at 1 site in Malaysia. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-15.
Sponsored by nor zila hassan malek · Phase 2, Interventional, and Prevention
RESEARCH HYPOTHESIS
-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 32 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with nor zila hassan malek as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
oral tablet Utrogestan 400mg daily for 2 days
Drug: utrogestan
tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days
Drug: Nifedipine
Oral Tablet Utrogestan 400 mg daily for 2 days
Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days
latency period interval between time of tocolysis and delivery
delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis
Time frame: 24 hours up to 7 days
Pregnancy outcomes
delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation
Time frame: 34 weeks of gestational age
Neonatal outcome
Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
Time frame: 24 hours
Maternal side effect
Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus
Time frame: 30 minutes up to 48 hours
This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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