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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00620724 |
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Date of registration:
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28/01/2008 |
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Primary sponsor: |
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Public title:
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Tocolytic Therapy in Conservative Management of Symptomatic Placenta Previa
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Scientific title:
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Maintenance Oral Nifedipine for Management of Symptomatic Placenta Previa : A Randomized Clinical Trial |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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110 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00620724 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Verspyck VE Eric, Pr |
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Address:
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Telephone:
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0232888990 |
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Email:
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eric.verspyck@chu-rouen.fr |
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Affiliation:
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Name:
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Verspyck Eric, MD, PhD |
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Address:
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Telephone:
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331232888745 |
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Email:
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eric.verspyck@chu-rouen.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of
the internal os at ultrasonography
- Placenta previa may be symptomatic with at least one episode of bleeding
- Estimated gestational age within 24 to 34 weeks
- Maternal age > 18 years
- Informed consent after received an explanation of the study and an information sheet
- Social affiliation
Exclusion Criteria:
- Premature rupture of membranes
- Severe bleeding requiring an immediate termination of pregnancy
- Abnormal fetal heart rates requiring an immediate termination of pregnancy
- Intrauterine fetal death
- Pre-eclampsia, chorioamnionitis, liver disease, severe chronic renal disease, heart
disease
- Abruptio placentae
- Nifedipine sensibility
- Drugs interaction with nifedipine
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Placenta Previa
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Intervention(s)
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Drug: Nifedipine
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Drug: Placebo
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Primary Outcome(s)
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Prolongation of pregnancy
[Time Frame: From allocation to the delivery]
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Secondary Outcome(s)
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Maternal outcomes i.e number episodes of bleeding, amount of bleeding, number of blood transfusion required
[Time Frame: At the end of the study]
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Secondary ID(s)
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2005/065/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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