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

Study Overview
=================
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

Official Title
-----------------
STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: utrogestan
* Drug: Nifedipine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Utrogestan<br>oral tablet Utrogestan 400mg daily for 2 days | Drug: utrogestan<br>* Oral Tablet Utrogestan 400 mg daily for 2 days<br>|
| Placebo Comparator: Nifedipine<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preterm labor