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Comparative Study on Tocolysis in Prevention of Preterm Labour
Sponsor study identifier
interventional
300
1 country
1
Study Start
October 25, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2017
Actual (reported)October 2, 2017
Actual (reported)October 25, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The time of delivery
6 months
Those women will be given Magnesium Sulfate for tocolysis
Those women will be given Ritodrine for tocolysis
Mohamed Atef Mohamed
Sohag, Egypt
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
First Submitted
August 26, 2017
First Posted
October 2, 2017
Study Start
October 25, 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Those women will be given Calcium Channel Blockers for tocolysis
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Primary Completion
April 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 2, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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