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STANDARD OPERATING PROCEDURE

MEDICAL TERMINATION OF PREGNANCY (MTP)

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1. PURPOSE

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2. SCOPE

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3. POLICY STATEMENT

• MTP services at this facility are provided in strict accordance with the MTP (Amendment) Act, 2021 and MTP Rules, 2021.
• All MTPs are performed only by qualified and trained Registered Medical Practitioners (RMPs) as defined under the Act.
• Patient confidentiality, dignity, informed consent, and non-coercion are upheld at all times.
• No MTP shall be performed for sex selection. Violation is a criminal offence under the PC&PNDT Act.
• Every patient has the right to refuse or withdraw consent at any stage.

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4. LEGAL FRAMEWORK (MTP AMENDMENT ACT, 2021 - KEY PROVISIONS)

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5. DEFINITIONS

• MTP: Deliberate termination of pregnancy by medical or surgical method before foetal viability.
• MMA: Medical Method of Abortion (Mifepristone + Misoprostol combination or Misoprostol alone).
• MVA: Manual Vacuum Aspiration.
• EVA: Electric Vacuum Aspiration.
• D&E: Dilatation and Evacuation.
• RMP: Registered Medical Practitioner.
• CAC: Comprehensive Abortion Care training.
• UPT: Urine Pregnancy Test.
• USG: Ultrasonography.

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6. RESPONSIBILITIES

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7. EQUIPMENT AND SUPPLIES

• Mifepristone 200 mg tablets
• Misoprostol 200 mcg tablets / vaginal pessaries
• Oxytocin, Ergometrine (for haemorrhage management)
• IV fluids (NS, RL)
• Analgesics (Ibuprofen, Paracetamol, Tramadol)
• Antibiotics (Doxycycline, Azithromycin, Metronidazole)
• Anti-D immunoglobulin (for Rh-negative patients)

• USG machine (for gestational age confirmation and location of pregnancy)
• MVA kit (IPAS-type double-valve syringe + cannulae sizes 4-12 mm)
• EVA machine with cannulae
• Dilatation instruments (Hegar dilators No. 4-16)
• Sponge-holding forceps, ring forceps, vulsellum
• Speculum (Cusco's / Sims')
• Foetal tissue examination tray
• Crash cart with defibrillator
• Suction apparatus
• Pulse oximeter, BP apparatus, ECG

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8. PRE-PROCEDURE PROTOCOL

Step 1: Registration and Triage

1. Patient registers in OPD. A unique registration number is assigned (two-identifier system per NABH AAC standards).
2. Triage nurse records: LMP, suspected gestational age, presenting complaint.
3. Patient is directed to Gynaecology OPD / MTP Clinic in a private, non-stigmatising environment.

Step 2: History and Clinical Assessment

1. Detailed menstrual history: LMP, cycle regularity, last unprotected sexual exposure.
2. Obstetric history: parity, previous MTPs, caesarean sections, uterine surgeries.
3. Medical history: bleeding disorders, cardiac disease, hepatic disease, adrenal insufficiency, seizure disorders, anticoagulant use, IUD in situ, corticosteroid use (relevant to Mifepristone contraindications).
4. Allergies to Mifepristone, Misoprostol, prostaglandins, latex.
5. General and pelvic examination.

Step 3: Investigations

Step 4: Counselling

1. A trained counsellor or gynaecologist provides unbiased, non-directive counselling.
2. Topics covered:
   • Options available: continuing pregnancy, adoption, MTP.
   • Methods of MTP appropriate for gestational age.
   • Benefits, risks, and limitations of each method.
   • What to expect during and after the procedure.
   • Signs of incomplete abortion, haemorrhage, infection (red flags requiring immediate return).
   • Post-abortion contraception options.
3. Confidentiality is explained and assured.
4. Counselling is documented in the MTP Counselling Record.

Step 5: Informed Consent

1. Consent is obtained by the performing gynaecologist or a designated RMP.
2. Language: Consent form is in the patient's vernacular language.
3. For minors (under 18 years): Consent of guardian is mandatory in addition to the patient's assent.
4. For mentally ill patients: Consent of the guardian is mandatory.
5. For competent adults: The woman's own consent is sufficient - spousal consent is NOT legally required under the MTP Act 2021.
6. The patient is informed of her right to withdraw consent at any time.
7. Signed consent form (MTP Consent - Form A) is filed in the medical record.
8. Form 1 (MTP Act): Opinion of the RMP(s) is recorded in prescribed Form 1 (single doctor up to 12 wks) or dual-opinion Form 1 (13 wks and above). This form is retained securely and is NOT to be disclosed.

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9. PROCEDURE PROTOCOL

Method A: Medical Method of Abortion (MMA) - Up to 9 Weeks (63 Days)

• Take 4 tablets of 200 mcg Misoprostol sublingually or vaginally 24-48 hrs after Mifepristone.
• Expect cramping and bleeding (heavier than normal period) within 1-4 hours.
• Paracetamol / Ibuprofen for pain relief.
• Return to facility if: soaking more than 2 pads/hour for 2 consecutive hours, fever >38°C beyond 24 hrs, severe abdominal pain not relieved by analgesics, no bleeding within 24 hrs.
• Follow-up USG / clinical review at 2 weeks to confirm complete abortion.

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Method B: Surgical Method - Manual Vacuum Aspiration (MVA) / Electric Vacuum Aspiration (EVA)

1. Confirm nil per oral status (if sedation/anaesthesia planned): minimum 6 hours for solids, 2 hours for clear fluids.
2. Cervical priming: Misoprostol 400 mcg sublingual or vaginal 2-3 hours before the procedure (especially for nulliparae and gestations > 8 weeks).
3. IV access established, pre-procedure vitals recorded.
4. Bladder emptied.
5. Pre-procedure antibiotic (Doxycycline 100 mg oral or IV).

1. Lithotomy position; vulvovaginal cleaning with antiseptic (Povidone iodine).
2. Bimanual examination to confirm uterine size and position.
3. Cusco's speculum inserted; cervix visualised and cleaned.
4. Vulsellum / single-toothed tenaculum applied on anterior lip of cervix.
5. Paracervical block: 10-20 ml of 1% Lignocaine at 4 and 8 o'clock positions (or as per anaesthesia plan).
6. Uterine sounding.
7. Cervical dilatation with Hegar dilators (one size larger than cannula to be used).
8. MVA cannula (size = gestational age in weeks) introduced; suction applied.
9. Evacuation performed with gentle rotatory and in-out movements until gritty feel, red foam without tissue, and uterine contraction around cannula are confirmed.
10. Oxytocin 10 IU IV / IM given after evacuation (routine uterotonics).
11. Aspirated contents inspected on a backlit tray with water to confirm villi/foetal parts appropriate for gestational age and to detect signs of molar or ectopic pregnancy.

1. Patient shifted to recovery room; monitored for 2-4 hours.
2. Vitals recorded every 15 minutes for 1 hour, then every 30 minutes.
3. Uterine tone and bleeding assessed.
4. IV fluids continued until oral intake is established.
5. Analgesics and anti-emetics as required.

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Method C: Dilatation and Evacuation (D&E) - 13 to 20 Weeks

1. Requires two-RMP opinion (Form 1, dual opinion).
2. Patient admitted as inpatient (minimum 24-hour admission).
3. Cervical priming: Misoprostol 400 mcg vaginal / sublingual every 3-4 hrs (up to 4 doses) OR Foley's catheter cervical balloon overnight OR Laminaria tent placement 12-24 hrs before procedure.
4. Procedure under spinal / general anaesthesia in OT.
5. D&E performed by senior gynaecologist with assisted lithotomy, systematic evacuation using large-bore forceps and suction.
6. USG guidance recommended for gestations >16 weeks.
7. Post-procedure: Oxytocin infusion (20-40 IU in 500 ml NS over 4 hours), foetal tissue inspection, IPD monitoring minimum 24 hours.
8. Anti-D given to Rh-negative patients within 72 hours of procedure.

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Method D: Medical Induction (Late Second Trimester / Beyond 20 Weeks)

• Misoprostol (600-800 mcg vaginal; repeat as per protocol)
• Oxytocin infusion (high-dose protocol under monitoring)
• Extra-amniotic instillation (if indicated)

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10. COMPLICATION MANAGEMENT

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11. POST-PROCEDURE CARE AND DISCHARGE CRITERIA

• Stable vitals for minimum 2 hours post-procedure.
• Able to tolerate oral fluids.
• Bleeding controlled (not soaking more than 1 pad / hour).
• Pain controlled on oral analgesics.
• Responsible adult escort available.
• Written discharge instructions given.

• Expect light to moderate bleeding for 1-2 weeks.
• Avoid intercourse, tampons, swimming for 2 weeks.
• Take all prescribed medications.
• Contraception initiated (as discussed - IUCD ideally same day for surgical MTP; oral contraceptives from same day for medical MTP).
• Emergency contact number for the facility clearly provided.
• Follow-up appointment date and time noted on discharge card.

• Fever >38°C persisting beyond 24 hours.
• Soaking more than 2 pads per hour for 2 consecutive hours.
• Severe abdominal pain not relieved by prescribed analgesics.
• Foul-smelling vaginal discharge.
• No passage of products / no bleeding after Misoprostol (medical MTP).
• Feeling faint or losing consciousness.

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12. POST-ABORTION CONTRACEPTION

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13. DOCUMENTATION AND RECORDS (NABH REQUIRED)

Confidentiality (Sec. 5A, MTP Act 2021): The identity of a woman who has undergone MTP shall not be revealed except to persons authorised by law. Violation is punishable with imprisonment up to 1 year or fine or both. All records to be stored in locked, access-controlled files / encrypted EMR modules.

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14. QUALITY INDICATORS (NABH QPS)

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15. STAFF TRAINING AND COMPETENCY

1. All gynaecologists performing MTP must hold valid CAC/MTP training certification recognised by MoHFW / FOGSI.
2. Competency assessment is conducted at the time of onboarding and annually thereafter.
3. Training records are maintained by the HR / Training department (NABH HRM standards).
4. Nursing staff receive annual training on: MTP law, patient confidentiality, complication recognition, medication administration.
5. Mock drills for haemorrhage and uterine perforation management - minimum once every 6 months.

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16. INFECTION CONTROL MEASURES (NABH IPSG / IC)

1. Sterile technique throughout all surgical procedures.
2. MVA / EVA cannulae and instruments: HIGH-LEVEL DISINFECTION (HLD) minimum; sterilisation preferred.
3. Speculum, dilators: autoclave sterilisation between uses.
4. Single-use items (cannulae, syringes, IV sets) to be discarded as per BMW rules.
5. Biomedical waste from MTP (foetal tissue, blood-soaked items): Yellow bag / Red bag as per BMW Rules 2016.
6. Hand hygiene (WHO 5 moments) before and after every patient contact.
7. PPE: sterile gloves, mask, eye protection for all procedures.

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17. PATIENT RIGHTS AND SPECIAL SITUATIONS

• Adolescents: Treated with sensitivity; guardian consent mandatory for those under 18.
• Rape survivors: Referred via police / medico-legal route; MTP to be performed on priority; Form 1 records 'pregnancy due to rape'; no police reporting of the woman herself; coordination with OSCE team.
• Disabled / mentally ill women: Guardian consent; ethics committee involvement if indicated.
• Unaccompanied women: MTP is still provided with the woman's own consent (adults); social worker to be engaged.
• Refusal of MTP: Respected unconditionally; patient referred for antenatal care if continuing pregnancy.
• Sex-selective MTP: Strictly prohibited; any request to be reported to Medical Superintendent. Staff member complicit is liable to prosecution under PC&PNDT Act.

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18. REFERENCES

1. The Medical Termination of Pregnancy Act, 1971 (as amended by MTP Amendment Act, 2021)
2. The MTP Rules, 2021 (notified October 2021)
3. National Health Mission - Comprehensive Abortion Care Training & Service Delivery Guidelines, 2023 (MoHFW, Government of India)
4. NABH Accreditation Standards for Hospitals, 6th Edition, January 2025
5. FOGSI Good Clinical Practice Recommendations - Medical Methods of Abortion, 2021
6. WHO Safe Abortion: Technical and Policy Guidance for Health Systems, 2nd Edition
7. PC & PNDT Act, 1994 (as amended)
8. Biomedical Waste Management Rules, 2016

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19. SOP REVIEW

• Annually (minimum)
• Whenever there is a change in MTP Act / Rules / MoHFW guidelines
• Following a sentinel event or significant adverse outcome
• At the direction of the Quality Committee or NABH assessor

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20. APPROVAL AND SIGNATURE

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Document Control: This is a controlled document. Uncontrolled copies are invalid. Latest version available on the Hospital Intranet / QMS portal. Previous versions are archived by the Quality Department.

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