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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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13 May 2013 |
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Main ID: |
NCT00671060 |
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Date of registration:
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29/04/2008 |
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Primary sponsor: |
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Public title:
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Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
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Scientific title:
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Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy, Inclusive, Not Accompanied by Complete Expulsion of the Contents of the Uterus |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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153 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00671060 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Vietnam
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Contacts
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women presents with spontaneous fetal death
- Gestational age of fetus between 14-28 weeks
Exclusion Criteria:
- Transmural uterine scar;
- Allergies or other contraindications to use of misoprostol;
- Placental abruption with active hemorrhage;
- Complete placenta previa;
- Extreme uterine structural anomalies;
- Or other contraindications to vaginal delivery of the fetus;
- Presentation in active labor (moderate to severe contractions every 10 minutes); or
- Four or more previous deliveries
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Intrauterine Fetal Demise
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Intervention(s)
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Drug: Misoprostol
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Primary Outcome(s)
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Successful Expulsion of Fetus and Placenta Within 48 Hours
[Time Frame: 48 hours]
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Secondary ID(s)
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1R01FD003107-01A1
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3.3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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