Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
NCT ID: NCT01985594
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
32 participants
INTERVENTIONAL
2013-11-30
2014-10-31
Brief Summary
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-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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Utrogestan
oral tablet Utrogestan 400mg daily for 2 days
utrogestan
Oral Tablet Utrogestan 400 mg daily for 2 days
Nifedipine
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
Nifedipine
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
Interventions
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utrogestan
Oral Tablet Utrogestan 400 mg daily for 2 days
Nifedipine
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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nor zila hassan malek
OTHER
Responsible Party
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nor zila hassan malek
medical officer
Principal Investigators
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nor azlin mohamed ismail
Role: PRINCIPAL_INVESTIGATOR
National University of Malaysia
Locations
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Obstetric and Gynaecology Department, National University of Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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national university of malaysia medical centre
Role: primary
References
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Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Other Identifiers
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FF-2013-407
Identifier Type: -
Identifier Source: org_study_id