ATT D10 Clinical guidance - Medication Abortion misoprostol alone.pdf

Last updated: March 3, 2023

Medication Abortion Clinical Guidance for VA Clinicians Treating

Veterans with Misoprostol Alone

VA’s medical benefits package excludes abortions except when: 1) the life or health of the pregnant Veteran would be endangered if the pregnancy were continued; or 2) the pregnancy is the result of an act of rape or incest. Care in the “medical benefits package” will be provided to individuals only if it is determined by appropriate health care professionals that the care is needed to promote, preserve, or restore the health of the individual and is in accord with generally accepted standards of medical practice.

(i) Promote health. Care is deemed to promote health if the care will enhance the quality of life or daily functional level of the veteran, identify a predisposition for development of a condition or early onset of disease which can be partly or totally ameliorated by monitoring or early diagnosis and treatment, and prevent future disease.

(ii) Preserve health. Care is deemed to preserve health if the care will maintain the current quality of life or daily functional level of the veteran, prevent the progression of disease, cure disease, or extend life span.

(iii) Restore health. Care is deemed to restore health if the care will restore the quality of life or daily functional level that has been lost due to illness or injury.

The purpose of this document is to provide clinical guidance to VA clinicians who are providing medication abortions with misoprostol alone to pregnant Veterans.

SCOPE/APPLICABILITY:

This guidance is for provision of medication abortion with misoprostol alone up to 77 days (11 weeks) gestation.1

CLINICIANS’ RESPONSIBILITIES:

Prior to provision of medication abortion with misoprostol alone, it is the clinician’s responsibility to:

1. Review eligibility criteria per VA regulations.

2. Obtain the patient’s prior and voluntary informed consent to use of a medication abortion with misoprostol alone, to include the required informed consent discussion elements, e.g., including complete abortion success rates, risks of continuing the pregnancy, risks of adverse outcomes associated with a medication abortion, benefits, and alternatives.

a. ACOG Patient-Facing FAQs Induced Abortion

3. Counsel the patient about what to expect with medication abortion with misoprostol alone, including side effects, medications to manage side effects, and warning signs.

1 Raymond EG, Harrison MS, Weaver MA. Efficacy of Misoprostol Alone for First-Trimester Medical Aboron: A Systemac Review. Obstet Gynecol. 2019;133(1):137-47.

https://www.acog.org/womens-health/faqs/induced-abortion

Office of Women’s Health VHACOReproductiveHealthTeam@va.gov

Last updated: March 3, 2023

4. Assess the patient’s need for clinical support services including social work, behavioral/mental health, pastoral or spiritual care. Place any necessary consults or referrals.

5. Assess the patient’s need for/desire for contraception (consistent with the contraceptive criteria information set forth in the clinical criteria below) following the medication abortion and offer it to the patient, who can accept or reject it.

6. Schedule follow-up either in person or via telehealth. See clinical criteria below.

7. Complete timely all required documentation/reporting requirements and enter into the patient’s medical record.

EVALUATION AND ANCILLARY TESTING RECOMMENDED PRIOR TO

MEDICATION ABORTION:

Ultrasound not necessary:

• regular menses

• patient is certain that their last menstrual period was within the prior 56 days

• no signs, symptoms or risk factors for ectopic pregnancy o Symptoms of ectopic pregnancy: light vaginal bleeding accompanied by lower abdominal or pelvic pain.

o Risk factors for ectopic pregnancy: previous ectopic pregnancy, prior tubal ligation or tubal surgery, IUD in place, history of pelvic inflammatory disease, endometriosis

Ultrasound should be considered:

• greater than 56 days since last menstrual period

• patient is uncertain of last menstrual period

• risk factors for ectopic pregnancy

• signs/symptoms of ectopic pregnancy (e.g., vaginal bleeding, pelvic pain)

Rh typing and administration of anti-d immunoglobulin:

• Evidence does not support blood-typing and administration of anti-D immunoglobulin if the gestational age on the anticipated medication abortion date will be ≤77 days.

Hematocrit and hemoglobin:

• Obtain if anemia is known or suspected

Pregnancy testing:

• Positive pregnancy test (home pregnancy test is acceptable)

• Serum quantitative βhCG only needed if plan is to follow serial quantitative βhCG after procedure. This is a matter of patient-provider preference.

mailto:VHACOReproductiveHealthTeam@va.gov

Last updated: March 3, 2023

CLINICAL ELIGIBILITY AND CONTRAINDICATIONS

Most patients at ≤77 days of gestation or fewer who are eligible for an abortion under

VA policy are candidates for a medication abortion with misoprostol alone.

Contraindications:

1. Known or suspected ectopic pregnancy

2. Allergy to misoprostol

3. Known coagulopathy or current anticoagulation therapy

Precautions:

1. IUD in place (need to rule out ectopic pregnancy due to significant increased risk with IUD in place; if intrauterine pregnancy, IUD can be removed prior to medication abortion)

2. Significant co-morbidities that may require stabilization prior to treatment

3. Known anemia <9.5g/dL as safety has not been studied and risk of transfusion, though low (<0.1%), is higher than with surgical evacuation

Beyond medical contraindications/precautions for medication abortion, the following are considerations for the clinician that may require additional counseling and/or result in offering only in-clinic aspiration abortion procedure:

• Patients who have difficulty with follow up (e.g., patients who have complex social considerations that may limit follow up)

• Patients unwilling to have uterine aspiration if medication abortion should fail

• Patient’s distance from a hospital (>60-minute drive from a hospital may be considered a contraindication)

• Patient’s access to a support person to be available while undergoing medication abortion to assist them with accessing care if having signs or symptoms concerning for a complication

Provide the following:

• Misoprostol 800 micrograms x 4 doses.

• Analgesics (e.g., NSAID, Tylenol) and antiemetics/antidiarrheals per clinician

(see Plan for Management of Side Effects, below). Patients can experience cramping and pain along with fever and chills while taking misoprostol.

• Patient instruction sheet and health facility emergency contact information

• Two high sensitivity pregnancy tests (HSPTs)

• Contraception as indicated. Provide any contraception except for intrauterine device or depo medroxyprogesterone acetate (Depo-Provera), both of which must be delayed until pregnancy is expulsed. If in-person follow-up is delayed, consider offering a bridge or barrier contraceptive method and counsel the patient that return to ovulatory function is within 7 days after abortion.

Last updated: March 3, 2023

The Veteran should take misoprostol 800 micrograms sublingually or vaginally every three hours for 3–4 doses.

• The patient should be instructed to take misoprostol under the tongue every three hours and continue for at least three doses. If bleeding and cramping occur after three doses and the patient feels that the pregnancy has passed, the regimen may be stopped. If no bleeding or cramping occurs or if the patient is unsure whether the pregnancy has passed, they should take the 4th dose.

• Patients with nausea may place the misoprostol tablets vaginally every three hours. The patient should switch to sublingual dosing once bleeding starts.

Patients should be informed that because vaginal tablets may not dissolve completely, tablets may be present in the vagina for days after the abortion.

• Review the instruction sheet with the pregnant Veteran.

Plan for Management of Side Effects:

Patients can experience cramping and pain, fever and chills, and nausea and diarrhea while taking misoprostol.

Crampy pain:

• Non-steroidal anti-inflammatory drugs (NSAIDS) o Ibuprofen 800mg po Q6–8 hours once cramping starts.

• Opioids if needed o Hydrocodone-acetaminophen 5/325mg, 1–2 tabs, po Q4–6 hours prn pain, dispense 4 tablets Fever/Chills:

• Acetaminophen 500–1000mg po Q6 hours as needed for pain, fever, and chills.

Acetaminophen and ibuprofen may be taken concurrently.

Nausea:

• Sample regimen: Promethazine 25mg po Q4–6 hours prn nausea

• Sample regimen: Ondansetron (Zofran) 8mg po Q8 hours prn nausea

Diarrhea:

• Loperamide (Imodium) may be used for diarrhea 4 mg po x 1, followed by 2 mg after each loose stool; maximum: 16 mg/day.

Last updated: March 3, 2023

Rule out Contraindications q Allergy to misoprostol q Known coagulopathy q Anticoagulant therapy

Assess need for ultrasound (US)

Gestational age may be >70 days q 1 st positive pregnancy test >6 weeks ago q LMP >70 days from prior visit q LMP uncertain by more than 1 week q Menstrual cycles are irregular q LMP did not feel like normal menses

Increased ectopic pregnancy risk q Prior ectopic pregnancy q IUD in place at the time of conception q Vaginal bleeding since LMP q Unilateral pelvic pain q History of tubal surgery or PID

If any checked, ultrasound indicated prior to

MAB: schedule ultrasound within 7 days

If any checked, ultrasound needed to rule out ectopic: schedule urgent ultrasound

Assess needs for labs (not routinely needed) q Anemia: check HGB/Hct if last HGB <10 or Hct <30%, or if history of severe anemia and no recent

HGB/Hct q Rh testing: Not routinely needed for 1 st trimester AB but may be offered (give Rhogam within 72 hours of mife if Rh-) q βhCG: not needed unless plan to confirm

Virtual care: telehealth and medications via mail OR In-person appointment q Telehealth and no US or labs needed: schedule or proceed with telehealth visit q Telehealth but needs US or labs: schedule US or lab appointment and schedule follow-up telehealth visit for med dispensing once confirmed to be medically eligible

No

Yes

OTHER CLINICAL CONSIDERATIONS:

1. Efficacy: In general, efficacy is less consistent with misoprostol alone when compared to mifepristone and misoprostol. Twenty-two percent of patients require procedural intervention (manual vacuum aspiration or suction dilation and curettage), and 6.8% have ongoing pregnancy. However, misoprostol alone is reasonable when mifepristone is not available.

2. Route of misoprostol administration: In general, vaginal, buccal, and sublingual administration are associated with increased efficiency, decreased ongoing pregnancy rates and allow an increased gestational age range for medication abortion compared to oral misoprostol administration.2

a. Vaginal administration is associated with fewer gastrointestinal side effects compared with buccal and sublingual administration.3

3. Medication abortion without definitive intrauterine pregnancy (IUP):

Medication abortion can be provided without prior ultrasound in some circumstances (see Evaluation and Ancillary Testing Recommended Prior to Medication Abortion above). For those patients who do require ultrasound, and a definitive IUP is not identified, medication abortion can be performed when ectopic pregnancy is unlikely based on criteria above, with counseling and close follow up.

2 Medical Management of First-Trimester Abortion - ACOG [Internet]. Available from:

http://www.acog.org/Resources-And-Publications/Practice- Bulletins/Committee-on-Practice-Bulletins- Gynecology/Medical-Management-of- First-Trimester-Abortion 3 Creinin MD, Danielsson K. Medical abortion in early pregnancy. In: Paul M, Lichtenberg S, Borgatta L, Grimes D, Subblefield P, Creinin M, editors. Management of Unintended and Abnormal Pregnancy: Comprehensive Abortion Care. Wiley- Blackwell; 2009.

Schedule follow-up:

In-person or by phone/telehealth

In-person follow-up (at ~7 days) q Confirm abortion complete by clinical history and either:

q Pre and post ultrasound q 80% drop in serum βhCG by 7 days (initial βhCG within 3 days of using mifepristone) q Negative urine hCG at 4 weeks q Offer contraception

Telehealth follow-up

Telehealth visit – days (provider) q If patient and provider think MAB is complete:

schedule follow-up call in 4 weeks to review urine pregnancy test results q If patient or provider think MAB is NOT complete:

schedule ultrasound q Offer contraception

Phone call or Telehealth visit 4 weeks (provider or RN) q Ensure home urine pregnancy hCG test negative, urgent evaluation if positive

Last updated: March 3, 2023

4. Antibiotics: Routine administration of prophylactic antibiotics is not recommended. The risk of infection after first trimester medication abortion is approximately 0.3%.

FOLLOW UP:

Standard follow up after medication abortion includes clinical evaluation 1–2 weeks following the first visit for medication abortion. Patients using misoprostol alone need to understand the importance of follow-up due to the increased risk of ongoing pregnancy or need for further treatment compared to treatment with mifepristone and misoprostol.

In-person clinical follow up. Follow-up may be done with transvaginal ultrasound 1–2 weeks after misoprostol to confirm successful abortion. Endometrial thickness does not indicate failed medication abortion.4

Contraception and family planning counseling should be offered at the time of follow-up, if not initiated at the time of abortion care.

Many people travel great distances to obtain medication abortion and in-person follow up may not be feasible. The following are acceptable alternatives to in-person follow up:

Telephone follow up: For those patients followed remotely, follow up can be performed by telephone at 1 week to confirm a successful abortion (bleeding and passing of tissue) with subsequent clinic or at home highly sensitive urine testing 4 weeks after treatment. If a patient has a positive pregnancy test but feels that the abortion was successful, they may take a second urine pregnancy test in two weeks. Two pregnancy tests should be mailed to the Veteran if telephone follow-up is planned. This avoids the need for the patient to present to a facility.4

*Note: Positive pregnancy tests or patient uncertainty about abortion success must be followed-up due to the risk of ongoing pregnancy with misoprostol alone.

How is incomplete medication abortion or ongoing pregnancy managed?

An incomplete medication abortion is defined as delayed expulsion or ongoing pregnancy. The incidence of incomplete medication abortion is about 22% with misoprostol alone. If diagnosis is unclear consult with specialist.

Managing incomplete medication abortion or ongoing pregnancy:

1. Plan a follow-up contact with the patient one week after dispensing treatment.

2. If the patient reports indicators of continuing pregnancy or ectopic pregnancy, evaluate with pelvic ultrasound AND serum quantitative βhCG.

3. If the patient does not report indicators of continuing pregnancy or ectopic pregnancy, then instruct the patient to perform the first highly sensitive

4 ACOG Practice Bulletin Medical abortion up to 70 days gestation 2020;136(4) e31-e46.

Last updated: March 3, 2023 pregnancy test (HSPT) 4 weeks after taking misoprostol (not earlier) and to contact their healthcare team if the result is positive.

4. If the first HSPT result is positive, but the patient has no indicators of continuing pregnancy or ectopic pregnancy, instruct the patient to perform the second HSPT in 1 week.

5. If the second HSPT result is also positive, evaluate with pelvic ultrasound, serum quantitative βhCG, additional urine testing, or uterine aspiration.

Delayed Expulsion

In the absence of excessive bleeding or pain clinicians can monitor patients based on symptoms.

Incomplete Medication Abortion

An incomplete abortion can be treated with a repeat dose of misoprostol, uterine aspiration, or expectant management depending on the clinical circumstances and patient preference.

Ongoing Pregnancy

Ongoing pregnancy can be treated with a repeat dose of misoprostol, uterine aspiration, or expectant management depending on the clinical circumstances and patient preference.

References

1. ACOG Practice Bulletin Medical abortion up to 70 days gestation 2020;136(4) e31-e46.

2. Creinin MD, Danielsson K. Medical abortion in early pregnancy. In: Paul M, Lichtenberg S, Borgatta L, Grimes D, Subblefield P, Creinin M, editors.

Management of Unintended and Abnormal Pregnancy: Comprehensive Abortion Care. Wiley- Blackwell; 2009.

3. National Abortion Federation. 2020 Clinical Policy Guidelines for Abortion Care.

4. Medical Management of First-Trimester Abortion - ACOG [Internet]. Available from: acog.org/Resources-And-Publications/Practice- Bulletins/Committee-on- Practice-Bulletins-Gynecology/Medical-Management-of- First-Trimester-Abortion.

5. Goldstone P, Michelson J, Williamson E. Effectiveness of early medical abortion using low-dose mifepristone and buccal misoprostol in women with no defined intrauterine gestational sac. Contraception. 2013 Jun;87(6):855–8.

6. Achilles SL, Reeves MF, Society of Family Planning. Prevention of infection after induced abortion: release date October 2010: SFP guideline 20102.

Contraception. 2011 Apr;83(4):295–309.

7. Perreira LK et al. Feasibility of telephone follow up after medical abortion.

Contraception 2010(81):143-9.

8. Chen MJ et al. Comparing office and telephone follow up after medical abortion.

Contraception 2016(94):122-6.

9. Ipas. Medical Abortion Contraindications and Precautions, last reviewed January 22, 2021. Accessed 8/25/22. www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/.

mailto:VHACOReproductiveHealthTeam@va.gov http://www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/ http://www.ipas.org/clinical-update/english/general-recommendations/medical-abortion-contraindications-and-precautions/