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

Phase 2

• Conditions: Preterm Labor
• Interventions: Drug: utrogestan; Drug: Nifedipine

• Registration Number: NCT01985594
• Lead Sponsor: nor zila hassan malek

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-10
• Last Update Submitted: 2013-11-10
• Study First Posted: 2013-11-15
• Last Update Posted: 2013-11-15
• Primary Completion: 2014-07
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Utrogestan	utrogestan	oral tablet Utrogestan 400mg daily for 2 days
Nifedipine	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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Obstetric and Gynaecology Department, National University of Malaysia Medical Centre; 🇲🇾 Cheras, Kuala Lumpur, Malaysia