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

Preterm Labor Clinical Trial

— UTROGESTAN  

Official title:

STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01985594
• Other study ID #: FF-2013-407
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 4, 2013
• Last updated: November 10, 2013
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2013
• Source: National University of Malaysia
• Contact: nor zila hassan malek
• Phone: 60139823219
• Email: nzhm_dr[@]yahoo.com
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Malaysia	Obstetric and Gynaecology Department, National University of Malaysia Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
nor zila hassan malek

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	latency period interval between time of tocolysis and delivery	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	Yes
Secondary	Pregnancy outcomes	delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation	34 weeks of gestational age	Yes
Secondary	Neonatal outcome	Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission	24 hours	Yes
Secondary	Maternal side effect	Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus	30 minutes up to 48 hours	Yes