Intraumbilical Misoprostol in Retained Placenta
Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial|
- delivery of placenta by medical intervention [ Time Frame: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein ] [ Designated as safety issue: Yes ]The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.
- vaginal bleeding after misoprostol use [ Time Frame: 30 minutes after umbilical vein injection of misoprostol ] [ Designated as safety issue: Yes ]using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.
- Number of Participants with Adverse Events as a Measure of Safety and Tolabrity [ Time Frame: 2 hours after umbilical vein injection of misoprostol ] [ Designated as safety issue: Yes ]Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache
|Study Start Date:||April 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Misoprostol
4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein
It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
Other Name: (Misotac)® tablet
Placebo Comparator: Normal saline
Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta
Drug: Normal saline
It is a placebo group
Other Name: Normal saline 0.9%
Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840813
|Maternity Teaching Hospital|
|Erbil city, Kurdistan region, Iraq, 383-65|
|Principal Investigator:||Shahla K. Alalaf, Clinical M.D||Hawler Medical University|
|Study Chair:||Sheelan S Rajab, High Diploma||, Shaheed Dr.Khalid General Hospital, Directorate of Health|