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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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12 December 2020 |
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Main ID: |
NCT02704780 |
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Date of registration:
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19/02/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Two Different Regimens of Misoprostol in Retained Placenta
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Scientific title:
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Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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509 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02704780 |
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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. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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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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Ariana Kh. Jawad, Assistant professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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KBMS |
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Name:
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Khalida M. Ameen, CABOG |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karkuk Medical college |
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Name:
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Khansa H. Abdul Rahman, MBChB |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maternity Teaching Hospital |
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Name:
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Namir G. Al Tawil, Professor |
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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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Name:
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Maryam B. Mahmood, FICOG |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sulaimani Maternity Hospital |
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Name:
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Jinan N. Hassan, IBMS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duhok university |
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Name:
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Bahar Q. Muhammad, CABOG |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maternity Teaching Hospital |
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Name:
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Salim A. Salim, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Azhar University |
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Name:
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Shahla K. Alalaf, professor |
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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 with a singleton pregnancy, delivered vaginally
- 28 weeks of gestation and more,
- had a prolonged third stage of labor (more than 30 minutes) despite active management,
- Haemodynamically stable and accept to participate in the trial
Exclusion Criteria:
- multiple pregnancies,
- previous caesarean delivery,
- haemodynamically instability, severe anaemia (haemoglobin concentration <8 g/dL),
- chorioamnionitis
- Refused to participate in the trial
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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Postpartum Haemorrhage
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Intervention(s)
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Drug: Misoprostol
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Primary Outcome(s)
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Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
[Time Frame: up to 30 minutes after intraumbilical injection]
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Secondary Outcome(s)
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The amount of blood loss vaginally in both groups
[Time Frame: up to 30 minutes after injection of placenta]
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side effects of misoprostol
[Time Frame: up to 24 hours after delivery of placenta]
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The time of delivery of placenta in both groups
[Time Frame: up to 30 minutes after delivery of the placenta]
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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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