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

Information source: National University of Malaysia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Labor

Intervention: utrogestan (Drug); Nifedipine (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: nor zila hassan malek

Official(s) and/or principal investigator(s):
nor azlin mohamed ismail, Principal Investigator, Affiliation: National University of Malaysia

Overall contact:
nor zila hassan malek, Phone: 60139823219, Email: nzhm_dr@yahoo.com

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

Clinical Details

Official title: STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR

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

Primary outcome: latency period interval between time of tocolysis and delivery

Secondary outcome:

Pregnancy outcomes

Neonatal outcome

Maternal side effect

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

nor zila hassan malek, Phone: 60139823219, Email: nzhm_dr@yahoo.com

Obstetric and Gynaecology Department, National University of Malaysia Medical Centre, Cheras, Kuala Lumpur 56000, Malaysia; Recruiting
national university of malaysia medical centre, Phone: 60391455950
nor zila hassan malek, Sub-Investigator
nor azlin mohamed ismail, Principal Investigator
Additional Information

Starting date: November 2013
Last updated: November 10, 2013

Page last updated: August 23, 2015

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