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

November 10, 2013 updated by: nor zila hassan malek

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Obstetric and Gynaecology Department, National University of Malaysia Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
34 weeks of gestational age
Neonatal outcome
Time Frame: 24 hours
Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
24 hours
Maternal side effect
Time Frame: 30 minutes up to 48 hours
Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus
30 minutes up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

nor zila hassan malek

Investigators

  • Principal Investigator: nor azlin mohamed ismail, National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 10, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 10, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2013-407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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