Comparative Study on Tocolysis in Prevention of Preterm Labour
Overview
- Phase
- Phase 4
- Intervention
- Magnesium Sulfate
- Conditions
- Preterm Labor Without Delivery
- Sponsor
- Assiut University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The time of delivery
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
mohamed atef mohamed
principal investigator
Assiut University
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Magnesium sulphate
Intervention: Magnesium Sulfate
Ritodrine
Intervention: Ritodrine
Calcium channel blocker
Intervention: Calcium Channel Blockers
Outcomes
Primary Outcomes
The time of delivery
Time Frame: 6 months