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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by National University of Malaysia
Sponsor:
Information provided by (Responsible Party):
nor zila hassan malek, National University of Malaysia
ClinicalTrials.gov Identifier:
NCT01985594
First received: November 4, 2013
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Preterm Labor
Drug: utrogestan
Drug: Nifedipine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR

Resource links provided by NLM:


Further study details as provided by National University of Malaysia:

Primary Outcome Measures:
  • latency period interval between time of tocolysis and delivery [ Time Frame: 24 hours up to 7 days ] [ Designated as safety issue: Yes ]
    delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis


Secondary Outcome Measures:
  • Pregnancy outcomes [ Time Frame: 34 weeks of gestational age ] [ Designated as safety issue: Yes ]
    delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation

  • Neonatal outcome [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission

  • Maternal side effect [ Time Frame: 30 minutes up to 48 hours ] [ Designated as safety issue: Yes ]
    Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus


Estimated Enrollment: 32
Study Start Date: November 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985594

Contacts
Contact: nor zila hassan malek 60139823219 nzhm_dr@yahoo.com

Locations
Malaysia
Obstetric and Gynaecology Department, National University of Malaysia Medical Centre Recruiting
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
Investigators
Principal Investigator: nor azlin mohamed ismail National University of Malaysia
  More Information

No publications provided

Responsible Party: nor zila hassan malek, medical officer, National University of Malaysia
ClinicalTrials.gov Identifier: NCT01985594     History of Changes
Other Study ID Numbers: FF-2013-407
Study First Received: November 4, 2013
Last Updated: November 10, 2013
Health Authority: Malaysia: Ministry of Health

Keywords provided by National University of Malaysia:
preterm labor

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Progesterone
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014