The use of 800 mcg of misoprostol prevents manual removal of the retained placenta in 80% of cases.
ID
Bron
Aandoening
Retained placenta
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Number of spontaneous delivered placentas;
2. Number of manual removals and amount of blood loss.
Achtergrond van het onderzoek
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?
Method
All women with retained placenta after vaginal birth will be included in our study. Misoprostol 800 mcg or placebo will be administered. If a final attempt to deliver the placenta by controlled cord traction after 45 minutes fails, manual removal of the placenta will be performed. Side effects will be registered.
Sample size
Considering the results of our pilotstudy and historical data we want to include 100 women.
Outcome
Primary: number of spontaneous delivered placentas, number of manual removals and amount of blood loss. Secondary: interval between delivery of the baby and administration of misoprostol, interval between administration of misoprostol and delivery of the placenta, placenta captiva.
Doel van het onderzoek
The use of 800 mcg of misoprostol prevents manual removal of the retained placenta in 80% of cases.
Onderzoeksproduct en/of interventie
In case of retained placenta: administration of either 800 mcg of misoprostol or placebo 60 minutes after birth of the baby, in absence of postpartum haemorrhage
Publiek
Giel Stralen, van
Leiden
The Netherlands
G.van_Stralen@lumc.nl
Wetenschappelijk
Giel Stralen, van
Leiden
The Netherlands
G.van_Stralen@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. All women with at least 25 completed pregnancy weeks and retained placenta;
2. At least 18 years of age;
3. Master the Dutch language in word and script.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Excessive blood loss (>1000 ml) within 60 minutes after the delivery of the newborn;
2. Allergy for misoprostol or one of its components.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL975 |
| NTR-old | NTR1002 |
| Ander register | : |
| ISRCTN | ISRCTN45330307 |