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

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. Identifier: NCT01985594
Recruitment Status : Unknown
Verified November 2013 by nor zila hassan malek, National University of Malaysia.
Recruitment status was:  Not yet recruiting
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
nor zila hassan malek, National University of Malaysia

Brief Summary:


-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

Condition or disease Intervention/treatment Phase
Preterm Labor Drug: utrogestan Drug: Nifedipine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : November 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Utrogestan
oral tablet Utrogestan 400mg daily for 2 days
Drug: utrogestan
Oral Tablet Utrogestan 400 mg daily for 2 days

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
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Neonatal outcome [ Time Frame: 24 hours ]
    Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission

  3. Maternal side effect [ Time Frame: 30 minutes up to 48 hours ]
    Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01985594

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Contact: nor zila hassan malek 60139823219

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Obstetric and Gynaecology Department, National University of Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000
Contact: national university of malaysia medical centre    60391455950      
Sub-Investigator: nor zila hassan malek         
Principal Investigator: nor azlin mohamed ismail         
Sponsors and Collaborators
nor zila hassan malek
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Principal Investigator: nor azlin mohamed ismail National University of Malaysia
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Responsible Party: nor zila hassan malek, medical officer, National University of Malaysia Identifier: NCT01985594    
Other Study ID Numbers: FF-2013-407
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Keywords provided by nor zila hassan malek, National University of Malaysia:
preterm labor
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Hormones, Hormone Substitutes, and Hormone Antagonists