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

Sponsor

nor zila hassan malek (Other)

Overall Status

Unknown status

CT.gov ID

NCT01985594

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor	Drug: utrogestan Drug: Nifedipine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

latency period interval between time of tocolysis and delivery [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

Pregnancy outcomes [34 weeks of gestational age]
delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation
Neonatal outcome [24 hours]
Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
Maternal side effect [30 minutes up to 48 hours]
Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetric and Gynaecology Department, National University of Malaysia Medical Centre	Cheras	Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

nor zila hassan malek

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

nor zila hassan malek, medical officer, National University of Malaysia

ClinicalTrials.gov Identifier:

NCT01985594

Other Study ID Numbers:

FF-2013-407

First Posted:

Nov 15, 2013

Last Update Posted:

Nov 15, 2013

Last Verified:

Nov 1, 2013

Keywords provided by nor zila hassan malek, medical officer, National University of Malaysia

preterm labor

Additional relevant MeSH terms:

Premature Birth

Obstetric Labor, Premature

Nifedipine

Progesterone

Study Results

No Results Posted as of Nov 15, 2013