Tocolysis in Prevention of Preterm Labor

Assiut University

Status and phase

Unknown

Phase 4

Conditions

Preterm Labor Without Delivery

Treatments

Drug: Magnesium Sulfate

Drug: Calcium Channel Blockers

Drug: Ritodrine

Study type

Interventional

Funder types

Other

Identifiers

NCT03298191

TPL

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Female

Ages

17 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)