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Trial record 3 of 4 for:    "Placenta Praevia" | "Anesthetics"

Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa

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ClinicalTrials.gov Identifier: NCT03542552
Recruitment Status : Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
ramy nasser, Assiut University

Brief Summary:
Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide

Condition or disease Intervention/treatment Phase
Placenta Previa Drug: Magnesium Sulfate Drug: Nifedipine Phase 3

Detailed Description:
There are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate, calcium channel blockers and β-sympathormimetics. In 2004 Sharma suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Active Comparator: Nifidipne
received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours
Drug: Nifedipine
received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours

Experimental: Magnisum sulphate
Patients in the MgSO4 group received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
Drug: Magnesium Sulfate
Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion




Primary Outcome Measures :
  1. The duration of prolongation of gestation [ Time Frame: 1 month ]
    measured from the time of enrollment to the time of delivery



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated gestational age : between 28 weeks and 37 week's gestation
  • Confirmed Placenta previa; either major or minor degrees.
  • Placenta previa with preterm uterine contractions

Exclusion Criteria:

  • Severe attack of bleeding requiring an immediate intervention.
  • Fetal heart rates instability or non-reassuring tracing
  • Intrauterine fetal death or major fetal anomalies.
  • If associated with abruptio placentae
  • Patients with known bleeding disorders or on anticoagulant therapy
  • Patients with severe medical disorders as myasthenia gravis documented magnesium toxicity.

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Responsible Party: ramy nasser, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03542552     History of Changes
Other Study ID Numbers: ONIMS
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Placenta Previa
Anesthetics
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Magnesium Sulfate
Nifedipine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Vasodilator Agents