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Tocolysis in Prevention of Preterm Labor

Comparative Study on Tocolysis in Prevention of Preterm Labour

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03298191
Enrollment
300
Registered
2017-10-02
Start date
2017-10-25
Completion date
2018-05-25
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor Without Delivery

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.

Interventions

DRUGMagnesium Sulfate

Those women will be given Magnesium Sulfate for tocolysis

Those women will be given Ritodrine for tocolysis

Those women will be given Calcium Channel Blockers for tocolysis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

false preterm labour

Intervention model description

complications ofthe drugs good response to drugs

Eligibility

Sex/Gender
FEMALE
Age
17 Years to 40 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
The time of delivery6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026