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Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial (UTROGESTAN)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by nor zila hassan malek, National University of Malaysia.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01985594
First Posted: November 15, 2013
Last Update Posted: November 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
nor zila hassan malek, National University of Malaysia
November 4, 2013
November 15, 2013
November 15, 2013
November 2013
July 2014   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • Pregnancy outcomes [ Time Frame: 34 weeks of gestational age ]
    delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation
  • Neonatal outcome [ Time Frame: 24 hours ]
    Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
  • Maternal side effect [ Time Frame: 30 minutes up to 48 hours ]
    Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus
Same as current
Not Provided
Not Provided
 
Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Preterm Labor
  • Drug: utrogestan
    Oral Tablet Utrogestan 400 mg daily for 2 days
  • Drug: 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
  • Active Comparator: Utrogestan
    oral tablet Utrogestan 400mg daily for 2 days
    Intervention: Drug: utrogestan
  • Placebo Comparator: 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
    Intervention: Drug: Nifedipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
32
October 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
 
NCT01985594
FF-2013-407
Yes
Not Provided
Not Provided
nor zila hassan malek, National University of Malaysia
nor zila hassan malek
Not Provided
Principal Investigator: nor azlin mohamed ismail National University of Malaysia
National University of Malaysia
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP