Condition category
Pregnancy and Childbirth
Date applied
30/09/2008
Date assigned
08/10/2008
Last edited
08/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Bullarbo

ORCID ID

Contact details

Kvinnokliniken Ostra Hospital
Sahlgrenska University Hospital
Gothenburg
41685
Sweden
+46 (0)31 343 40 00
maria.bullarbo@vgregion.se

Additional identifiers

EudraCT number

2008-001346-92

ClinicalTrials.gov number

Protocol/serial number

EudraCT number: 2008-001346-92

Study information

Scientific title

Medical treatment with nitroglycerin for management of retained placenta: a multicentre trial

Acronym

Study hypothesis

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

The Regional Ethical Committee of Gothenburg, approved on the 5th May 2008 (ref: 107-08)

Study design

Multicentre randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Oxytocin (Syntocinon®), glyceryl trinitrate (Nitromex®), folic acid (Folacin®)

Primary outcome measures

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 trial start date

01/10/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant exclusion criteria

1. Excessive vaginal bleeding
2. Preterm labour
3. Daily medication
4. Placenta accreta/percreta
5. Known uterine abnormailty

Recruitment start date

01/10/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Kvinnokliniken Ostra Hospital
Gothenburg
41685
Sweden

Sponsor information

Organisation

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

Sponsor details

Regionens Hus
Vanersborg
462 80
Sweden
+46 521 27 57 00
post@vgregion.se

Sponsor type

Government

Website

http://www.vgregion.se/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes