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Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Amendment Rules, 2003

FORM F
[See Proviso to Section 4(3), Rule 9(4) and Rule 10(1A)]

FORM FOR MAINTENANCE OF RECORD IN RESPECT OF PREGNANT WOMAN BY GENETIC CLINIC/ULTRASOUND CLINIC/IMAGING CENTRE

 1. Name and address of the Genetic Clinic/Ultrasound Clinic/Imaging Centre.

2. Registration No.

3. Patient’s name and her age

4. Number of children with sex of each child

5. Husband’s/Father’s name

6. Full address with Tel. No., if any

7. Referred by (full name and address of Doctor(s)/Genetic Counselling Centre (Referral note to be preserved carefully with case papers)/self referral

8. Last menstrual period/weeks of pregnancy

9. History of genetic/medical disease in the family (specify)

Basis of diagnosis:

            (a)  Clinical

            (b) Bio-chemical

            (c) Cytogenetic

            (d) Other (e.g.radiological, ultrasonography etc. specify)

10. Indication for pre-natal diagnosis

A. Previous child/children with:

(i)    Chromosomal disorders

(ii)   Metabolic disorders

(iii)  Congenital anomaly

(iv)  Mental retardation

(v)   Haemoglobinopathy

(vi)  Sex linked disorders

(vii)  Single gene disorder

(viii) Any other (specify)

B. Advanced maternal age (35 years)

C. Mother/father/sibling has genetic disease (specify)

D. Other (specify)

11. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered Medical Practitioner) who performed it.

Non-Invasive

(i) Ultrasound  (specify purpose for which ultrasound is to done during pregnancy)

[List of indications for ultrasonography of pregnant women are given in the note below]

 Invasive                                                            

(ii)   Amniocentesis

(iii)  Chorionic Villi aspiration

(iv)  Foetal biopsy

(v)   Cordocentesis

(vi)  Any other (specify)

12. Any complication of procedure – please specify

13. Laboratory tests recommended[3]

(i)   Chromosomal studies

(ii)   Biochemical studies

(iii)  Molecular studies

(iv)  Preimplantation genetic diagnosis

14. Result of

     (a) pre-natal diagnostic procedure (give details)                             

     (b) Ultrasonography              Normal/Abnormal

         (specify abnormality detected, if any).

15. Date(s) on which procedures carried out.

16. Date on which consent obtained. (In case of invasive)

17. The result of pre-natal diagnostic procedure were conveyed to ……….on ……………

18. Was MTP advised/conducted?

19. Date on which MTP carried out.

                                            
Date: 

                                                               
                           

                                       Name, Signature and Registration number of the Place Gynaecologist/Radiologist/Director of the Clinic

 
DECLARATION OF PREGNANT WOMAN

I, Ms. ________________ (name of the pregnant woman) declare that by undergoing ultrasonography /image scanning etc. I do not want to know the sex of my foetus.

 Signature/Thump impression of pregnant woman

___________________________________________________________________________________

3 Strike out whichever is not applicable or not necessary

DECLARATON OF DOCTOR/PERSON CONDUCTING ULTRASONOGRAPHY/IMAGE SCANNING

I, __________________ (name of the person conducting ultrasonography/image scanning) declare that while conducting ultrasonography/image scanning on Ms. ___________ (name of the pregnant woman), I have neither detected nor disclosed the sex of her foetus to any body in any manner.

Name and signature of the person conducting ultrasonography/image scanning/

Director or owner of genetic clinic/ultrasound clinic/imaging centre. 

Important Note:

(i) Ultrasound is not indicated/advised/performed to determine the sex of foetus except for diagnosis of sex-linked diseases such as Duchenne Muscular Dystrophy, Haemophilia A & B etc.

(ii) During pregnancy Ultrasonography should only be performed when indicated. The following is the representative list of indications for ultrasound during pregnancy.

(1) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.

(2) Estimation of gestational age (dating).

(3) Detection of number of foetuses and their chorionicity.

(4) Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive failure/MTP failure.

(5) Vaginal bleeding / leaking.

(6) Follow-up of cases of abortion.

(7) Assessment of cervical canal and diameter of internal os.

(8) Discrepancy between uterine size and period of amenorrhoea.

(9) Any suspected adenexal or uterine pathology / abnormality.

(10) Detection of chromosomal abnormalities, foetal structural defects and other abnormalities and their follow-up.

(11) To evaluate foetal presentation and position.

(12) Assessment of liquor amnii.

(13) Preterm labour / preterm premature rupture of membranes.

(14) Evaluation of placental position, thickness, grading and abnormalities (placenta praevia, retroplacental haemorrhage, abnormal adherence etc.).

(15) Evaluation of umbilical cord – presentation, insertion, nuchal encirclement, number of vessels and presence of true knot.

(16) Evaluation of previous Caesarean Section scars.

(17) Evaluation of foetal growth parameters, foetal weight and foetal well being.

(18) Colour flow mapping and duplex Doppler studies.

(19) Ultrasound guided procedures such as medical termination of pregnancy, external cephalic version etc. and their follow-up.

(20) Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus sampling (CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnio-infusion, intrauterine infusion, placement of shunts etc.

(21) Observation of intra-partum events.

(22) Medical/surgical conditions complicating pregnancy.

(23) Research/scientific studies in recognised institutions.

 Person conducting ultrasonography on a pregnant women shall keep complete record thereof in the clinic/centre in Form – F and any deficiency or inaccuracy found therein shall amount to contravention of provisions of section 5 or section 6 of the Act, unless contrary is proved by the person conducting such ultrasonography.

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