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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT01840813 |
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Date of registration:
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18/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intraumbilical Misoprostol in Retained Placenta
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Scientific title:
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Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01840813 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Iraq
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Contacts
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Name:
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Sheelan S Rajab, High Diploma |
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Address:
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Telephone:
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Email:
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Affiliation:
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, Shaheed Dr.Khalid General Hospital, Directorate of Health |
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Name:
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Shahla K. Alalaf, Clinical M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hawler Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women having singleton pregnancy
- 28 weeks of gestation or more delivered vaginally
- prolongation of the third stage of labour (more than 30 min) following active
management of third stage of labour
Exclusion Criteria:
- Who refused to participate in the trial
- Multiple pregnancies
- Previous Caesarean Section
- Haemodynamically unstable
- Severe anaemia (haemoglobin less than 8gm/dl)
- Chorioamnionitis
Age minimum:
15 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Retained Placenta
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Intervention(s)
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Drug: Normal saline
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Drug: Misoprostol
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Primary Outcome(s)
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delivery of placenta by medical intervention
[Time Frame: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein]
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Secondary Outcome(s)
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vaginal bleeding after misoprostol use
[Time Frame: 30 minutes after umbilical vein injection of misoprostol]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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