Tocolysis in Prevention of Preterm Labor

Study Overview
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Brief Summary
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Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women . Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor . A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.

Official Title
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Comparative Study on Tocolysis in Prevention of Preterm Labour

Conditions
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Preterm Labor Without Delivery

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Ritodrine
* Drug: Calcium Channel Blockers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . Gestational age between 24-37weeks Symptoms such as low backache , cramping ,pelvic pressure, excessive vaginal discharge and vaginal spotting . Regular uterine contractions at least of 30 seconds duration at a rate of more than 4/30 minutes Cervical changes dilatation less than 3cm,effacement lessthan50%. Intact membranes. Exclusion criteria Active vaginal bleeding and placental abruption. Chorioamnionitis and intrauterine infection Fetal conditions : fetal death or distress, lethal congenital or chromosomal abnormalities and intra uterine growth restriction Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe preeclampsia and cardiac diseases Drug specific contraindications(contraindication of tocolysis)

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: complications ofthe drugs good response to drugs
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnesium sulphate<br> | Drug: Magnesium Sulfate<br>* Those women will be given Magnesium Sulfate for tocolysis<br>|
| Experimental: Ritodrine<br> | Drug: Ritodrine<br>* Those women will be given Ritodrine for tocolysis<br>|
| Experimental: Calcium channel blocker<br> | Drug: Calcium Channel Blockers<br>* Those women will be given Calcium Channel Blockers for tocolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of delivery |  | 6 months |