Romania had a very restrictive
legislation from 1960 to 1989. Both abortion and contraception were
banned and declared illegal by law. In 1990, right for abortion
was recognised and there were one million legal abortions during
that year. The number has reduced to 150,000 in the year 2001 due
to increase in the use of contraception. Liberalisation of abortion
was difficult in the initial phases. To promote the need for framing
recommendations and standards, regularization was required. Representatives
from the MOH and NGOs helped in promoting the idea. The total induced
abortion rate in Romania is 2.1 and live-abortion to live-birth
ratio is 1:6. Between 1960 and 1989, there were 7,000 maternal deaths
due to illegal abortions, but now the MMR has declined radically.
After assessment of the abortion status, the regulatory group started
working on standards, recommendations and guidelines. This was followed
by the terminology problem i.e. whether to develop standards or
recommendations or guidelines or protocols. There is no discussion
about extending the rights to perform abortion by mid-level providers
or other healthcare providers. Gynaecologists are proposing the
concept of IUD insertion by non–gynaecologists (family doctors).
Another aspect that is affecting the provision of abortion services
is the change in financing. MOH develops the policies and funding
comes from the Health Insurance Scheme. This leads to the need to
consult these bodies in the process of developing the guidelines.
The incharge is the College of Physicians. Termination of pregnancy
on request is legal in Romania.
Guidelines set general recommendations
for services.
They are systematically developed statements which assist clinicians
and patients in making decisions about appropriate treatment for
specific conditions.
Adherence to guidelines may be monitored, but guidelines are not
usually binding.
Standards are specific norms and may be framed as minimum standards.
For example, as a minimum standard, all abortion-providing facilities
must offer on- site contraceptive information. Role of standards
is to provide a basis for ongoing quality assurance, help reduce
unnecessary care and costs, help protect providers in malpractice
suits, provide ongoing medical education and encourage research.
The developing process of the standards was done in consultation
with major stakeholders like Ministry of Health and Family, National
College of Physicians, National Society of Obstetrics and Gynaecology,
National Health Insurance House, technical institutes of the Ministry
of Health and Family and key relevant non- governmental organizations.
The process was based on review of the relevant medical literature,
known patient- outcomes and existing standards and guidelines (US
NAF, UK RCOG, French, etc.)
The Contents of the guidelines and standards are as follows :
• Legal aspects
• Organisation of services (who should perform abortions,
when and where should abortions be performed, facilities, registration
and reporting)
• Accreditation and audit of services
• Counseling and informed consent
• Pre-abortion procedures (blood tests, Rh typing and Rh immune
globulin administration, vaginal bacteriology and cervical cytology,
ultrasound, use of peri-operative antibiotics, pre-operative endocarditis
prophylaxis)
• Surgical abortion (pre-operative, operative and post-operative
procedure)
• Medical abortion
• Anaesthesia
• Complications (emergency procedures, bleeding, perforations)
• Post-operative care
• Post-abortion contraception
• Evaluation of evacuated uterine contents
• Fetal tissue disposal
• Processing of instruments
The format includes policy statements, standards, recommendations
and options (Table 2.1.4)
Policy
Statement – Medical
induction with mifepristone and misoprostol is an effective method
for early abortion. Adequate counseling and follow-up care enhance
its safety and acceptability. Three types of practice policies (NAF
model):
Standards are intended
to be applied rigidly. They must be followed in virtually all cases.
Exceptions are rare and difficult to justify.
Recommendations are
steering in nature. They do not have the force of standards, but
when not adhered to, they should be documented using, rational clinical
justification. These allow some latitude in clinical management.
Options are neutral with
respect to a treatment choice. They merely note that different interventions
are available and that different people make different choices.
They may contribute to the educational process, and require no justification.
The Future Tasks to pursue are :
• To clarify the MOH’s policies on reimbursment of elective
termination of pregnancy.
• To implement the standards in pilot facilities through protocols
• To develop an "audit" tool to test/monitor an
individual facility adherence to the guidelines/standards/protocols
and to measure progress towards the guidelines/standards/ protocols
across facilities
• To pilot test the audit tool
• To revise the guidelines/standards/protocols as necessary
• To disseminate the package more broadly.
| TABLE 2.1.4
: STANDARDS AND RECOMMENDATIONS |
| Standards |
Recommendation |
Option |
| The patient must be informed about the need for follow-up
contact to ensure that she is no longer pregnant. |
Written instructions should be given to all patients. |
- |
| The patient must be informed about the efficacy, side-effects,
and risks, especially excessive bleeding and teratogenicity
associated with the medications to be used. |
The patient’s consent to surgical abortion if medical
abortion fails must be documented. |
- |
| Patient instructions must include information about use of
medications at home and symptoms of abortion complications. |
The facility must provided, an emergency contact service on
a 24- hour basis. |
Ultrasonography may be used routinely. |
The patient’s gestation should not be greater than
49 days.
|
Gestational age must be documented |
Analgesics may be used as needed unless there are contraindications |
| Patient comfort-level during the abortion procedure must be
considered |
- |
Analgesics may be used as needed unless there are contraindications |
| Ectopic pregnancy must be considered when ultrasonography
shows a suspicious adnexal mass, or no pre-abortion sonography
has been performed, and there is no or minimal bleeding in response
to medications. |
Ultrasonography should be used to confirm and document gestational
age when physical examination and LMP are substantially discordant. |
Ultrasonography may be used routinely. |
| Completion of the abortion must be documented by clinical
means, ultrasonography or by hCG testing. |
Ultrasonography should be used to evaluate completion of the
abortion when the expected bleeding does not occur after medications. |
Follow up ultrasound on day 15 may be done as a routine. |
| |
|
|
|
