PICO: P = population; I = intervention; C = comparator; O = outcome(s)^[1] 

Pre-abortion

Rhisoimmunization

PICO 1: No anti-D administration in unsensitized Rh-negative individuals seeking abortion (see Recommendation 8 [NEW])

PICO question: For an unsensitized Rh-negative individual seeking abortion at < 12 weeks of gestation, is no administration of anti-D a safe and effective alternative to routine anti-D administration?

P: Unsensitized Rh-negative individuals seeking abortion at < 12 weeks (undergoing either medical or surgical abortion)

I: No anti-D administration

C: Routine anti-D administration

O:

• Rate of isoimmunization in subsequent pregnancy
• Rate of antibody formation after initial pregnancy.

Pain management for surgical abortion

PICO 2: Pain control for surgical abortion at < 14 weeks of gestation (see Recommendations 11 and 12 [NEW])

PICO question: For a pregnant person seeking surgical abortion at < 14 weeks of gestation, is pain control with any particular method (I) safer, more effective and/or more satisfactory/acceptable compared with pain control with a different method or no pain control (C)?

P: Pregnant persons seeking surgical abortion at less than 14 weeks of gestation.

I:

• Paracervical block (PCB) [this includes the different concentrations, type (lidocaine), carbonated versus not, depth of injection]
• PCB with premedication
• Intravenous (IV) conscious sedation plus PCB
• General anaesthesia
• Topical anaesthesia (e.g. lidocaine)
• Non-pharmacological intervention (music, acupuncture, “verbicaine”, etc.)

C:

• No PCB
• PCB alone
• PCB with premedication
• IV conscious sedation plus PCB

O:

• Effectiveness (maximum pain as measured by visual analogue scale; VAS)
• Anxiety scores using VAS
• Safety (complications related to pain control methods, use of supplemental narcotic, use of any additional analgesic medication, duration of recovery time, hospital admission), side-effects
• Satisfaction/acceptability.

PICO 3: Pain control for surgical abortion at ≥ 14 weeks of gestation (see Recommendations 11, 13 and 14 [NEW])

PICO question: For a pregnant person seeking surgical abortion at ≥ 14 weeks of gestation (including cervical priming prior to the procedure), is pain control with any particular method (I) safer, more effective and/or more satisfactory/acceptable compared with pain control with a different method or no pain control (C)?

P: Pregnant persons seeking surgical abortion at 14 weeks of gestation or above

I:

• PCB [this includes the different concentrations, type (lidocaine), carbonated versus not, depth of injection]
• PCB with premedication
• IV conscious sedation plus PCB
• General anaesthesia
• Topical anaesthesia (e.g. lidocaine)
• Non-pharmacological intervention (music, acupuncture, “verbicaine”, etc.)

C:

• No PCB
• PCB alone
• PCB with premedication
• IV conscious sedation plus PCB

O:

• Effectiveness (maximum pain as measured by VAS)
• Anxiety scores using VAS
• Safety (complications related to pain-control methods, use of supplemental narcotic, use of any additional analgesic medication, duration of recovery time, hospital admission), side-effects
• Satisfaction/acceptability.

Pain management for medical abortion

PICO 4: Pain control for medical abortion at < 14 weeks of gestation (see Recommendation 15)

PICO question: For a pregnant person seeking medical abortion at < 14 weeks of gestation, is pain control with any particular (i) pharmacological method (given prophylactically or after onset of pain) or (ii) non-pharmacological method safer, more effective and/or more satisfactory/acceptable compared with any other such method or no treatment/placebo?

P: Pregnant persons seeking medical abortion at < 14 weeks of gestation

I:

1. Pharmacological methods [Timing: prophylactic or after onset of pain]

• Ibuprofen
• Acetaminophen plus codeine
• Anti-emetics
• Loperamide
• Tramadol

2. Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)

C:

1. Pharmacological methods [Timing: prophylactic or after onset of pain]

• Ibuprofen
• Acetaminophen plus codeine
• Anti-emetics
• Loperamide
• Tramadol

2. Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)
3. No treatment/placebo

O:

• Effectiveness (maximum pain as measured by VAS)
• Safety (complications related to pain-control methods, use of any supplemental narcotic, use of any additional analgesic medication), side-effects
• Effectiveness of medical abortion regimen, defined as successful completion without additional surgical intervention
• Time to expulsion
• Satisfaction/acceptability.

PICO 5: Pain control for medical abortion at ≥ 14 weeks of gestation (see Recommendation 16 [NEW])

PICO question: For a pregnant person seeking medical abortion at ≥ 14 weeks of gestation, is pain control with any particular (i) pharmacological method (given prophylactically or after onset of pain) or (ii) non-pharmacological method safer, more effective and/or more satisfactory/acceptable compared with any other such methods or no treatment/placebo?

P: Pregnant persons seeking medical abortion at 14 weeks of gestation or above

I:

• Pharmacological methods [Timing: prophylactic or after onset of pain]

• Pretreatment (ibuprofen, acetaminophen plus codeine, antiemetics, loperamide, tramadol)
• IV opiates
• PCB

2. Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)

C:

1.  Pharmacological methods [Timing: prophylactic or after onset of pain]

• Pretreatment (ibuprofen, acetaminophen plus codeine, antiemetics, loperamide, tramadol)
• IV opiates
• PCB

2. Non-pharmacological methods (music, acupuncture, “verbicaine”, etc.)
3. No treatment/placebo

O:

• Effectiveness (maximum pain as measured by VAS)
• Safety (complications, use of any supplemental narcotic, use of any additional analgesic medication), side-effects
• Effectiveness of medical abortion regimen, defined as successful completion without additional surgical intervention
• Time to expulsion
• Satisfaction/acceptability.

Cervical priming

PICO 6a: Cervical priming at < 12 weeks of gestation (see Recommendation 17)

PICO question: For a pregnant person seeking surgical abortion at < 12 weeks of gestation, is cervical priming effective, safe and acceptable?

P: Pregnant persons seeking surgical abortion < 12 weeks

I: Cervical priming with medication or mechanical methods

C: Cervical priming with placebo, with medication (using different routes, doses or treatment intervals) or with different mechanical methods

O:

• Effectiveness
• Satisfaction/acceptability
• Safety.

PICO 6b: Cervical priming at ≥ 12 weeks with medications (comparing different regimens) (see Recommendations 18b–d [NEW])

PICO question: For a pregnant person seeking surgical abortion at ≥ 12 weeks of gestation, is cervical priming with mifepristone plus misoprostol or with mifepristone alone a safe, effective and satisfactory/acceptable alternative to cervical preparation with misoprostol alone?

P: Pregnant persons seeking surgical abortion at ≥ 12 weeks

I: Cervical priming with

• Mifepristone plus misoprostol [various routes, doses, intervals]
• Mifepristone alone [various routes, doses, intervals]

C: Cervical priming with misoprostol alone [various routes, doses, intervals]

O:

• Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
• Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
• Satisfaction (client and provider)/acceptability
• Cost (comparative cost and cost to the client).

PICO 7: Cervical priming at ≥ 12 weeks with medications compared with mechanical methods (see Recommendation 18b [NEW])

PICO question: For a pregnant person seeking surgical abortion at ≥ 12 weeks of gestation, is cervical priming with medical methods (mifepristone, misoprostol, or both) a safe, effective and satisfactory/acceptable alternative to mechanical methods (laminaria, foley bulb, dilapan)?

P: Pregnant persons seeking surgical abortion at ≥ 12 weeks

I: Cervical priming with medical methods

• Mifepristone alone
• Misoprostol plus mifepristone
• Misoprostol alone

C: Cervical priming with mechanical methods (i.e. laminaria, foley bulb, dilapan)

O:

• Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
• Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
• Satisfaction (client and provider)/acceptability
• Cost (comparative cost and cost to the client).

PICO 8: Cervical priming at ≥ 12 weeks with medication(s) plus laminaria compared with laminaria alone (see Recommendation 18d [NEW])

PICO question: For a pregnant person seeking surgical abortion at ≥ 12 weeks of gestation, is cervical priming with medication(s) plus laminaria a safe, effective and satisfactory/acceptable alternative to cervical preparation with laminaria alone?

P: Pregnant persons seeking surgical abortion at ≥ 12 weeks

I: Cervical priming with medication(s) plus laminaria

• Mifepristone plus misoprostol plus laminaria
• Misoprostol plus laminaria
• Mifepristone plus laminaria

C: Cervical priming with laminaria alone

O:

• Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
• Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
• Satisfaction (client and provider)/acceptability
• Cost (comparative cost and cost to the client).

PICO 9: Cervical priming at ≥ 12 weeks by mechanical method(s) before dilatation and evacuation (D&E) (see Recommendation 18 [NEW])

PICO question: For a pregnant person seeking surgical abortion (D&E) at ≥ 12 weeks of gestation, is cervical priming with one mechanical method a safe, effective and satisfactory/acceptable alternative to cervical priming with a different mechanical method?

P: Pregnant person seeking surgical abortion at ≥ 12 weeks

I: Cervical priming with one mechanical method before D&E

C: Cervical priming with a different mechanical method before D&E

O:

• Effectiveness (pre-procedure cervical dilatation, need for further dilatation, ease of procedure, time to complete procedure)
• Safety (complications, need for additional interventions, pre- and post-procedure pain), side-effects
• Satisfaction (client and provider)/acceptability
• Cost (comparative cost and cost to the client).

Abortion

New medical methods for abortion

PICO 10: Medical abortion with letrozole plus misoprostol, compared with misoprostol alone (see Recommendation 27c [NEW])

PICO question: For a pregnant person seeking medical abortion, is medical abortion with letrozole plus misoprostol a safe, effective and satisfactory/acceptable alternative to medical abortion with misoprostol alone?

P: Pregnant persons seeking medical abortion (all gestational ages)

I: Medical abortion with letrozole plus misoprostol [various routes, doses, intervals]

C: Medical abortion with misoprostol alone [various routes, doses, intervals]

O:

• Effectiveness (ongoing pregnancy rate, procedure completed without surgical intervention)
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Satisfaction/acceptability
• Cost (comparative and cost to the client).

PICO 11: Medical abortion with letrozole plus misoprostol, compared with mifepristone plus misoprostol

PICO question: For a pregnant person seeking medical abortion, is medical abortion with letrozole plus misoprostol a safe, effective and satisfactory alternative to medical abortion with mifepristone plus misoprostol?

P: Pregnant persons seeking medical abortion (all gestational ages)

I: Medical abortion with letrozole plus misoprostol [various routes, doses, intervals]

C: Medical abortion with mifepristone plus misoprostol [various routes, doses, intervals]

O:

• Effectiveness (ongoing pregnancy rate, completed without surgical intervention)
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Satisfaction/acceptability
• Cost (comparative and cost to the client).

PICO 12: Medical abortion with mifepristone plus letrozole, compared with misoprostol alone

PICO question: For a pregnant person seeking medical abortion, is medical abortion with mifepristone plus letrozole a safe, effective and satisfactory alternative to medical abortion with misoprostol alone?

P: Pregnant person seeking medical abortion

I: Medical abortion with mifepristone plus letrozole [various routes, doses, intervals]

C: Medical abortion with misoprostol alone [various routes, doses, intervals]

O:

• Effectiveness (ongoing pregnancy rate, completed without surgical intervention)
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Satisfaction/acceptability
• Cost (comparative and cost to the client).

Missed abortion at < 14 weeks of gestation

PICO 13: Medical management of missed abortion with mifepristone plus misoprostol (see Recommendation 31 [NEW])

PICO question: For a pregnant person with missed abortion at < 14 weeks of gestation, is medical management with mifepristone plus misoprostol a safe, effective and satisfactory/acceptable alternative to medical management with misoprostol alone?

P: Pregnant persons with missed abortion < 14 weeks

I: Medical management with mifepristone plus misoprostol [various routes, doses, intervals]

C: Medical management with misoprostol alone [routes, doses, intervals]

O:

• Effectiveness (failed expulsion/ongoing retained products, completed without surgical intervention)
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Satisfaction/acceptability
• Cost of treatment.

PICO 14: Medical management of missed abortion with all regimens (see Recommendation 31 [NEW])

PICO question: For a pregnant person with missed abortion at < 14 weeks of gestation, is medical management (all regimens) a safe, effective and satisfactory/acceptable alternative to expectant management?

P: Pregnant persons with missed abortion < 14 weeks

I: Medical management (all regimens)

C: Expectant management

O:

• Effectiveness (failed expulsion/ongoing retained products, completed without surgical intervention)
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Satisfaction/acceptability
• Cost of treatment.

PICO 15: Surgical management of missed abortion (see Recommendation 31 [NEW])

PICO question: For a pregnant person with missed abortion at < 14 weeks of gestation, is surgical management a safe, effective and satisfactory/acceptable alternative to medical or expectant management?

P: Pregnant persons with missed abortion < 14 weeks

I: Surgical management

C:

• Medical management
• Expectant management

O:

• Effectiveness (failed expulsion/ongoing retained products, completed without surgical intervention
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Satisfaction/acceptability
• Cost of treatment.

Self-management approaches

Self-management of medical abortion (see Recommendation 49)

PICO 16: Self-management of medical abortion

PICO question: For a pregnant person seeking medical abortion, is self-management of the process of medical abortion (assessing eligibility, administration of mifepristone and/or misoprostol, self-assessing outcome/success), without direct supervision of a trained health worker, a safe, effective and satisfactory/acceptable alternative to medical abortion managed by a trained health worker?

P: Pregnant persons seeking medical abortion at any gestational age

I: Pregnant persons self-managing the process of medical abortion (in whole) without direct supervision of a trained health worker

C: Medical abortion managed by a trained health worker (all medication abortion regimens)

O:

• Effectiveness (success of abortion without need for surgical intervention following the procedure)
• Safety (serious adverse events and complications)
• Satisfaction/acceptability
• Physical and emotional experience (side-effects, positive and negative emotions, internalized stigma), knowing when to seek medical care (unscheduled visits, phone calls to the clinic, emergency visits)
• Cost.

PICO 16a: Self-assessment of eligibility for MA

PICO question: For a pregnant person seeking medical abortion, is self-assessment of eligibility^[2] for medical abortion a safe, effective and satisfactory/acceptable alternative to eligibility assessment by a physician or other trained health-care provider?

P: Pregnant persons seeking medical abortion at any gestational age

I: Pregnant persons self-managing the first part of the medical abortion process by self-assessing their eligibility for medical abortion without direct supervision of a health-care provider

C: Eligibility assessment performed by a trained health-care provider

O:

• Proportion of pregnant persons deemed eligible for medical abortion
  • Proportion of pregnant persons who were deemed ineligible due to gestational age
  • Proportion of pregnant persons who were deemed ineligible due to contraindications
• Accuracy of these assessments when measured against an independent verifier and/or diagnostic standard
• Ongoing pregnancy
• Completed without surgical intervention
• Safety (serious adverse events and complications)

PICO 16b: Self-administering medications for medical abortion

PICO question: For a person seeking medical abortion, is self-administration of medications for medical abortion, when provided with instructions for their use from a reliable source, a safe, effective and satisfactory/acceptable alternative to administration of medications by a trained health worker?

P: Pregnant persons seeking medical abortion at any gestational ages

I: Pregnant persons self-administering the medications for medical abortion (as part of the medical abortion process) without direct supervision by a health-care provider (but with instructions from a reliable source of health care)

C: Administration of medications for medical abortion by a trained health worker

O:

• Pregnant persons’ adherence to the recommended medical abortion regimen following instructions
• Effectiveness (ongoing pregnancy rate, completed without surgical intervention)
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment
• Physical and emotional experience (side-effects, positive and negative emotions, internalized stigma), knowing when to seek medical care (unscheduled visits, phone calls to the clinics, emergency visits)
• Satisfaction/acceptability
• Cost (comparative and cost to the client).

PICO 16c: Self-assessment of the outcome of the medical abortion process

PICO question: For an individual who has undergone medical abortion, is self-assessment of the outcome/success of medical abortion a safe, effective and satisfactory/acceptable alternative to assessment of the outcome/success by a trained health worker?

P: Individuals who have undergone medical abortion

I: Pregnant persons self-managing the last part of the medical abortion process by self-assessing the outcome/success of the abortion without direct supervision by a trained health worker

C: Assessment of outcome/success of abortion by a trained health worker

O:

• Effectiveness (proportion of pregnant persons assessed to have successful abortion, accuracy of these assessments when measured against an independent verifier and/or diagnostic standard)
• Ongoing pregnancy rate
• Completed without surgical intervention
• Safety (serious adverse events and complications), side-effects
• Expulsion time from initiation of treatment;
• Physical and emotional experience (side-effects, positive and negative emotions, internalized stigma), knowing when to seek medical care (unscheduled visits; phone calls to the clinics, emergency visits)
• Satisfaction/acceptability
• Cost (comparative and cost to the client).