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Clinical Trials/NCT03298191
NCT03298191
Unknown
Phase 4

Comparative Study on Tocolysis in Prevention of Preterm Labour

Assiut University1 site in 1 country300 target enrollmentOctober 25, 2017

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2017
End Date
May 25, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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