Informed consent

INFORMED CONSENT
for examinations at the Maternal-Fetal Medicine Center and Fetal Medicine LTD

…………………………………………………………………

patient’s full name

This is informed consent for the examinations performed at the Maternal-Fetal Medicine Center and individual practice for specialized outpatient medical care (IPSOMC) Fetal Medicine LTD.

For the purposes of its activity, the individual practice for outpatient medical care Fetal Medicine LTD processes personal data of natural persons in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, the Personal Data Protection Act, the normative acts in the field of healthcare and this Policy for the protection of personal data.

The purpose of the examinations is prenatal diagnostic testing or screening of the pregnant woman and the fetus.

The main highly specialized examinations performed are first-trimester screening, fetal morphology and fetal growth monitoring with Doppler velocimetry.

Other examinations that are performed at the Maternal-Fetal Medicine Center and IPSOMC Fetal Medicine LTD are within the scope of Obstetrics and Gynecology.

The examination may be attended by one companion over the age of 16. If there are persons under the age of 16, the parents assume full responsibility in case it is necessary to communicate an unfavorable diagnosis and the resulting stress to the child. If a state of pandemic is declared, the presence of a companion in the medical facility is prohibited.

Each examination begins with asking questions and filling out the medical record.

At the end of each examination, you will receive a summary of the results. In the case of a detected abnormality, a variant of normal or an unclear condition of the fetus or the mother, options for follow-up, investigations, behavior and prognosis will be discussed.

Ultrasound examination cannot rule out all structural abnormalities and genetic syndromes or chromosomal abnormalities, as well as developmental abnormalities. The quality of the ultrasound examination depends on the BMI (body mass index)/weight of the patient. Excess weight makes the examination very difficult, as well as the detection of various anomalies.

There is no scientific data on adverse reactions or harm to the fetus and the pregnant woman from a routine ultrasound examination.

During the examinations, some abdominal/ vaginal pressure may be applied by the doctor in order to examine the fetus. This may cause some discomfort. Please inform the doctor promptly if the discomfort is too much for you. If you ask the examination to be discontinued, it is cancelled and the General Terms and Conditions from www.pregnancy.bg shall apply.

The first-trimester screening is carried out from 11 weeks of gestation and 0 days to 13 weeks of gestation and 6 days, determined from the day of conception in case of in-vitro pregnancy or, when the fetus is between 45 and 84 mm, in case of spontaneous pregnancy. The examination starts with asking questions and filling out the medical record, measuring blood pressure 2 times on each arm (more if necessary), and taking a blood sample of up to 10 ml. Then ultrasound examination is done through the abdomen and on rare occasions transvaginal ultrasound is required. The echography includes a careful examination of the fetus, measurement (biometrics) of the fetus and dating of the pregnancy, determination of the probable term of delivery, screening for the most common chromosomal abnormalities (Down’s, Edwards’ and Patau’s syndrome) and screening for Preeclampsia.

The screening for chromosomal abnormalities is based on assessment including maternal age, nuchal translucency measurement, heart rate, and biochemical results. This is a screening, not a diagnosis, and if the results show some deviations, additional genetic tests can be performed at your request, in order to confirm or rule out a high risk. Screening for chromosomal abnormalities has a detection rate of up to 95%, with a false positive rate of 5%.

Screening for Preeclampsia is based on the collected information, blood pressure measurement of both arms, Doppler velocimetry of the uterine arteries and biochemistry. Screening for Preeclampsia has a detection rate of up to 90%, with a false positive rate of 15%. For women at high risk, it is recommended to take Aspirin 150 mg every evening, starting at 16 weeks of gestation and ending at 36 weeks of gestation, in the absence of other contraindications. The prevention prevents up to 89% of the occurrence of Preeclampsia.

The duration of the examination is 30 minutes, but it depends on the position of the fetus.

At high risk for gestational diabetes, it is recommended to perform an ORAL GLUCOSE TOLERANCE TEST at 28 weeks of gestation and consultation with an endocrinologist if the result is abnormal.

After the examination, the patient should receive the final results in person. The purpose of the discussion is to provide complete and accurate information, as well as a pregnancy follow-up plan and the possibility of additional tests.

Fetal morphology is performed from 19 to 22 weeks of gestation and includes an extremely detailed examination of the fetus. During the examination of the fetal heart, your doctor may be quieter because this requires a higher level of concentration. Fetal biometry, inspection of the placenta, amniotic fluid and monitoring of the blood flow to the uterus (womb) of the mother are performed. At the request of the patient, a transvaginal ultrasound can be done to determine the risk of premature birth, which is safe for the fetus and the pregnant woman. The duration of the examination is 30 minutes for a singleton pregnancy and 60 minutes for twins, but it depends on the position of the fetus. If the position of the fetus does not allow inspection, the additional examination may be performed on the same day or another day.

The fetus growth monitoring with Doppler velocimetry after 28 weeks of gestation is associated with fetal biometry, amniotic fluid assessment and Doppler velocimetry of the main blood vessels of the fetus and the mother. The position of the fetus and the placenta is determined. Since the pregnancy at this stage is advanced, the movements of the fetus are limited, and its bones are of increased density, it is not possible to examine the fetus thoroughly, but only partially. The duration of the examination is 15 minutes for a singleton pregnancy and 30 minutes for twins.

The examination documents are received only in person!

At the end of the examination, you will receive photos by email, at the doctor’s choice. In order to protect the environment, we do not provide photos on paper. We reserve the right not to provide photos and/ or a recording of the examination. You may receive a record of the examination on external media for an additional fee. Taking pictures/videos during the examination is prohibited!

We inform you that all examinations are performed after their prepayment and confirmation.
Examinations without booked and confirmed appointments are charged at double the price, according to the published price list.

You may ask questions throughout the examination within the relevant time. The questions should be related to the examination. We reserve the right not to answer questions of a general nature.

By signing this informed consent, you declare that you are familiar with and agree to the general conditions and policy for the protection of personal data on our website www.pregnancy.bg.

The payment of the examination or the package fee according to the pricelist is not subject to refund under any circumstances.

By signing this informed consent, you declare that you agree to be examined by our team and to all the conditions listed above.

By signing this informed consent, you agree your medical record be used for scientific and research purposes.

         SIGNATURE ………….…………                                Date ………………………..

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