NCT01985594UnknownPhase 2
STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR
nor zila hassan malek1 site in 1 country32 target enrollmentStarted: November 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- latency period interval between time of tocolysis and delivery
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.
Exclusion Criteria
- •Multiple pregnancies
- •Women with Preterm Prelabour Rupture of Membrane
- •Fetal death
- •Women with bad obstetric history
- •Women with history of cervical incompetence
- •Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan
- •Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta
- •Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage
- •Cervical dilatation of 3cm or more
- •Patients with previous tocolytic treatment during this pregnancy
- •Women who refuse to participate in this study
Arms & Interventions
Utrogestan
Active Comparator
oral tablet Utrogestan 400mg daily for 2 days
Intervention: utrogestan (Drug)
Nifedipine
Placebo Comparator
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
Intervention: Nifedipine (Drug)
Outcomes
Primary Outcomes
latency period interval between time of tocolysis and delivery
Time Frame: 24 hours up to 7 days
delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis
Secondary Outcomes
- Neonatal outcome(24 hours)
- Pregnancy outcomes(34 weeks of gestational age)
- Maternal side effect(30 minutes up to 48 hours)
Investigators
nor zila hassan malek
medical officer
National University of Malaysia
Study Sites (1)
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