Tocolysis in Prevention of Preterm Labor

• Status: Unknown status
• Trial end date: 2018-05-25
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Calcium; Calcium Channel Blockers; Calcium, Dietary; Magnesium Sulfate; Ritodrine

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

• Drug specific contraindications(contraindication of tocolysis)