- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542552
Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa
July 26, 2021 updated by: ramy nasser, Assiut University
Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Assiut University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The duration of prolongation of gestation
Time Frame: 1 month
|
measured from the time of enrollment to the time of delivery
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
May 19, 2018
First Submitted That Met QC Criteria
May 19, 2018
First Posted (Actual)
May 31, 2018
Study Record Updates
Last Update Posted (Actual)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Obstetric Labor Complications
- Placenta Diseases
- Obstetric Labor, Premature
- Placenta Previa
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
- Nifedipine
Other Study ID Numbers
- ONIMS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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