Postpartum Haemorrhage, Retained Placenta
Conditions
Keywords
Retained placenta, Misoprostol, double blind, Randomization, Haemorrhage
Brief summary
This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia
Detailed description
The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta
Interventions
DRUGMisoprostol
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol | up to 30 minutes after intraumbilical injection | complete delivery of placenta after injection of intraumbilical misoprostol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The amount of blood loss vaginally in both groups | up to 30 minutes after injection of placenta | To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta |
| The time of delivery of placenta in both groups | up to 30 minutes after delivery of the placenta | the time interval estimation from the injection to complete delivery of the placenta |
| side effects of misoprostol | up to 24 hours after delivery of placenta | Any side effects related to misoprostol after the injection (Fever, severing , diarrhea) |
Countries
Iraq
Outcome results
None listed