Nitroglycerin for management of retained placenta: a multicentre trial
| ISRCTN | ISRCTN34755982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34755982 |
| Clinical Trials Information System (CTIS) | 2008-001346-92 |
| Protocol serial number | EudraCT number: 2008-001346-92 |
| Sponsor | The Vastra Gotaland Regional Council (Vastra Gotalandsregionen) (Sweden) |
| Funder | The Gothenburg Medical Society (Goteborgs Lakaresallskap) (Sweden) - Regional FoU resources |
- Submission date
- 30/09/2008
- Registration date
- 08/10/2008
- Last edited
- 08/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maria Bullarbo
Scientific
Scientific
Kvinnokliniken Ostra Hospital
Sahlgrenska University Hospital
Gothenburg
41685
Sweden
| Phone | +46 (0)31 343 40 00 |
|---|---|
| maria.bullarbo@vgregion.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Medical treatment with nitroglycerin for management of retained placenta: a multicentre trial |
| Study objectives | To study the effect of medical treatment with 1 mg of nitroglycerin administered sublingually on retained placenta, i.e. does placenta detach on the treatment? 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 1 mg sublingually seems to have an 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. Every woman who 30 minutes after vaginal delivery has a retained placenta and can be recruited to the study according to inclusion and exclusion criteria will be asked to participate in the study. The multicentre trial will be performed in the Swedish cities of Gothenburg, Trollhattan, Boras and Norrkoping. |
| Ethics approval(s) | The Regional Ethical Committee of Gothenburg, approved on the 5th May 2008 (ref: 107-08) |
| Health condition(s) or problem(s) studied | Retained placenta |
| Intervention | If placenta has not detached 30 minutes after delivery the patient will be given 10 IU oxytocin (Syntocinon®) intravenously. Five minutes later the doctor tries to expel the placenta by gentle traction of the umbilical cord. If the placenta doesn't detach the patient will be asked to participate in the study and will randomly be selected to either active treatment or placebo. Of 120 patients included in the study 60 will randomly be selected to be administered two tablets of 0.5 mg glyceryl trinitrate (Nitromex®) sublingually, and 60 patients in the placebo group will be administered two tablets of 5 mg folic acid (Folacin®). The administration will occur approximately 45 minutes after the vaginal delivery and only once. If placenta does not detach 5 minutes later the patient will be taken to the operative theatre for manual removal of the placenta in regional or general anaesthesia. The follow up of the outcomes will be performed up to 30 minutes after inclusion to the study, more specifically until the placenta is detached. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oxytocin (Syntocinon®), glyceryl trinitrate (Nitromex®), folic acid (Folacin®) |
| Primary outcome measure(s) | The numbered of detached placentas following sequential treatment with 10 IU oxytocin intravenously and 1 mg nitroglycerin sublingually compared to placebo group. |
| Key secondary outcome measure(s) | 1. To measure blood loss on the treatment compared to placebo group, at 0 minutes, 5 minutes and 15 minutes. The amount of blood loss will be measured before and after detachment and the total blood loss until placental delivery will be measured. 2. To study possible side effects such as headache, palpitations, hot flushes, at 0 minutes, 5 minutes and 15 minutes 3. To study possible effects on blood pressure and pulse rate, at 0 minutes, 5 minutes and 15 minutes |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Healthy women with no medication, aged 18 - 45 years 2. Uncomplicated vaginal delivery 3. Term pregnancy (greater than 37 weeks) 4. Retained placenta 45 minutes after delivery 5. The woman wishes to participate in the study 6. No excessive vaginal bleeding (less than 500 ml) 7. Circulatory stability |
| Key exclusion criteria | 1. Excessive vaginal bleeding 2. Preterm labour 3. Daily medication 4. Placenta accreta/percreta 5. Known uterine abnormailty |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Kvinnokliniken Ostra Hospital
Gothenburg
41685
Sweden
41685
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
