Background: retained placenta occurs in 3% of all deliveries. The results from a pilot study indicate that medical treatment with a combination of oxytocin and the utero-relaxing agent nitroglycerin adminstered 1mg sublingually seems to have effect. The primary aim of this study is to investigate in a larger multicentre trial if the good results from the pilot study using nitroglycerin for management of retained placenta can be confirmed.
Conditions
Interventions
Trade Name: Nitromex 0,5mg resoritablet
Product Name: Nitromex resoritablet 0,5mg
Product Code: GTN
Pharmaceutical Form: Sublingual tablet
CAS Number: 55630
Other descriptive name: GLYCERYL TRINITRATE
Sponsors
No sponsor
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy woman with no medication 2. Uncomplicated vaginal delivery 3. Term pregnancy (>37 weeks) 4. Retained placenta 45 minutes after delivery 5. The woman wishes to participate in the study 6. No excessive vaginal bleeding (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Excessive vaginal bleeding 2. Preterm labour 3. Daily medication 4. Placenta accreta/percreta 5. Known uterine abnormailty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: To study the effect of medical treatment with 1mg of nitroglycerin administered sublingually on retained placenta, i.e.does placenta detach on the treatment.;Secondary Objective: Secondary objectives: To measure blood loss on the treatment compared to placebo group, to study possible side effects such as headache, palpitations, hot flushes, and to study possible effects on blood preassure and pulse rate.;Primary end point(s): Primary end point is to evaluate in a multicenter double-blind randomised study evaluate if sequental medical treatment with oxytocin 10 IU intravenously and 1mg of Nitromex sublingually is effective in detaching retained placenta compared to oxytocin 10 IU and placebo. | — |
Countries
Sweden
Outcome results
None listed