Nitroglycerin for management of retained placenta: a multicentre trial

ISRCTN	ISRCTN34755982
DOI	https://doi.org/10.1186/ISRCTN34755982
EudraCT/CTIS number	2008-001346-92
Secondary identifying numbers	EudraCT number: 2008-001346-92

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

Kvinnokliniken Ostra Hospital
Sahlgrenska University Hospital
Gothenburg
41685
Sweden

Phone	+46 (0)31 343 40 00
Email	maria.bullarbo@vgregion.se

Study information

Study design	Multicentre randomised placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Oxytocin (Syntocinon®), glyceryl trinitrate (Nitromex®), folic acid (Folacin®)
Primary outcome measure	The numbered of detached placentas following sequential treatment with 10 IU oxytocin intravenously and 1 mg nitroglycerin sublingually compared to placebo group.
Secondary outcome measures	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
Overall study start date	01/10/2008
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	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

Sponsor information

The Vastra Gotaland Regional Council (Vastra Gotalandsregionen) (Sweden)
Government

Regionens Hus
Vanersborg
462 80
Sweden

Phone	+46 521 27 57 00
Email	post@vgregion.se
Website	http://www.vgregion.se/
"ROR"	https://ror.org/00a4x6777

Funders

Funder type

Research organisation

The Gothenburg Medical Society (Goteborgs Lakaresallskap) (Sweden) - Regional FoU resources

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan