To assess the effectiveness of misoprostol in the management of retained placenta. Will 800 micrograms of misoprostol orally reduce the need for manual removal under general anaesthesia and prove to be a safe alternative?
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of manual removals and amount of blood loss.
Secondary outcome
Interval between administration of misoprostol and delivery of the placenta,
placenta captiva.
Possible side effects of misoprostol; diarrhoea, abdominal pain, nausea,
dyspepsia, vomiting, headache and dizziness.
Background summary
*If a retained placenta is left untreated, there is a high risk of maternal
death. However manual removal of the placenta is an invasive procedure with its
own serious complications of haemorrhage, infection or genital tract trauma*
(Carroli G, Bergel E, Umbilical vein injection for management of retained
placenta (review). Cochrane Database Syst Rev. 2001)
If manual removal of the retained placenta can be prevented this may decrease
associated maternal morbidity ande mortality.
Study objective
To assess the effectiveness of misoprostol in the management of retained
placenta. Will 800 micrograms of misoprostol orally reduce the need for manual
removal under general anaesthesia and prove to be a safe alternative?
Study design
Multicenter, placebocontrolled randomised trial.
Intervention
Will 800 micrograms of misoprostol orally.
Study burden and risks
Women who receive placebo might be at risk for increased blood loss.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
All women with at least 25 completed pregnancy weeks and retained placenta (the placenta has not been born within 60 minutes after the birth of the child), in the abcense of postpartum haemorrhage.
Exclusion criteria
Excessive blood loss (>1000 ml) within 60 minutes after the delivery of the newborn. Allergy for misoprostol or one of its components.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006371-20-NL |
| CCMO | NL15196.058.06 |