Vaginal misoprostol administered at home after mifepristone for abortion - RU486

Journal of Family Practice, April, 1997 by Eric A. Schaff, Lisa S. Stadalius, Steven H. Eisinger, Peter Franks

Appendix

Health Problems and Medications Exclusion
Criteria for Taking Mifepristone

Exclusion Health Problems
Adrenal disease
   Asthma (severe)
   Glaucoma
   Blood pressure: too low
   Sickle cell anemia
   Allergy to prostaglandin
   Liver disease (severe)
   Respiratory disease (severe)
   Cardiovascular disease:
   Hypertension untreated of poorly controlled
   Congestive heart failure
   History of blood clots (thromboembolic or pulmonary embolus)
   Angina
   Valvular disease (eg, aortic stenosis or mitral stenosis)
   Arrhythmia
   Anemia (Hgb <10 g/dL)
   Blood clotting defect
   Presence of intrauterine device
   Insulin-dependent diabetes mellitus
   Age 35 years or older   smokes >20 cigarettes/day   another
   cardiovascular risk factor:
   Diabetes mellitus
   Hyperlipidemia
   Hypertension
   Family history of ischemic heart disease with early death
   (age 50 or younger)

Exclusion Medications (taking medications on long-term basis)
   Steroid medications
   Salicylates, eg, aspirin
   Anticoagulant, eg, warfarin
   Prostaglandin-inhibiting medications, eg, ibuprofen, indomethacin,
   naproxen
   Oxytocics: methylergonovine maleate (Methergine)
   Anti-psychotic medication, such as:
   clozapine(Cloraril)
   prochlorperazine edisylate (Compazine)
   haloperidol (Haldol)
   thioridazine hydrochloride (Mellaril)
   fluphenazine hydrocholoride (Prolixin)
   trifluoperazine hydrocholoride (Stelazine)
   chlorpromazine (Thorzine)
   perphenazine (Trilafon)
TABLE 1
Baseline Demographic and Clinical Variables for Study Group of 166
Pregnant Women, July-November 1996

Variable             n (%)     Mean     SD (range)

Race/ethnicity
   White              132(80)
   African American   23(14)
   Hispanic           7(4)
   Asian              4(2)

Age, y                          27.2    6.0(18-42)
   18-21              33(20)
   22-25              38(23)
   26-29              43(26)
   30-41              52(31)

Body surface area, [m.sup.2]    1.71    0.17(1.40-2.27)

Gestational age, days          43.3     6.4(32-56)
   32-42              70(42)
   43-49              57(34)
   50-56              39(24)

Prior pregnancy      120(72)    2.8 *   1.7(1-9)

Prior birth          90(54)     1.6 *   0.7(1-3)

Prior abortion       76(46)     1.5 *   0.8(1-5)

Means refer only to subjects with any prior pregnancies, births,
or abortions.
TABLE 2
Baseline Demographic and Clinical Variables
of Delayed Responders, n=5

               Body Surface
                  Area,      Parity   Gestational   Initial Day
Race    Age    [m.sup.2]               Age, days    of Bleeding

White   25        1.60         0          34             4
White   23        1.76         0          36             4
White   20        1.64         1          38             6
White   19        1.75         0          47             2
White   18        1.79         0          50             5

              No. of Days    Cardiac Activity at    No. of Doses of
Race    Age   of Bleeding   First Follow-up Visit   Misoprostol Used

White   25        12                 No                   2
White   23        37                 No                   3
White   20        12                 No                   2
White   19        12                 Yes                  1 *
White   18        19                 No                   2

* Subject did not initially use misoprostol
because of early bleeding.
TABLE 3
Time Intervals from Mifepristone to Bleeding, Misoprostol to
Bleeding and Cramping, and Onset to Cessation of Bleeding, N=166

Subjects                   Time Interval        Mean   SD (range)
n (%)

166 (100)             Onset of bleeding after    3.0    0.8 (1-5)
                      mifepristone, days
134 * (81)            Onset of bleeding after   13.5    3.2 (1-21)
                      misoprostol, hours
133 ([dagger]) (80)   Onset of cramping after    2.1    2.7 (1-20)
                      misoprostol, hours
166 (100)             No. of days of bleeding   16.3   11.7 (2-67)

* 32 subjects began moderate bleeding prior to using misoprotol
(18 did not require misoprostol).

([dagger]) 33 subjects did not experience significant cramping,
or cramping began prior to using misoprostol.
TABLE 4
Subjects with Side Effects to Mifepristone (N=166)
and Misoprostol (n=148)

                          Side Effects to   Side Effects to
                           Mifepristone       Misoprostol
Side Effects                    n (%)             n (%)

Nausea worse                   60 (36)           53 (36)
Vomiting worse                 23 (14)           28 (19)
Diarrhea worse                 13 (8)            32 (22)
Cramping worse                 81 (49)          135 (91)
Dizziness worse                37 (22)           51 (37)
Spotting                       49 (30)           55 (38)
Bleeding                       48 (29)          144 (97)
Headache worse                 29 (18)           28 (19)
Fever, warmth, or chills       33 (20)           55 (37)
TABLE 5
Results of Acceptability Questionnaire, N=166

                                              Choices on Scale

                                       Strongly
                                       Disagree,   Disagree,   Neutral,
Statement                               n (%)       n (%)      n (%)

Overall, the procedure went well.       1 (1)       2 (1)      4 (2)

The cramping pain was acceptable.       7 (4)      15 (9)     18 (11)

The bleeding was acceptable               0         4 (2)      4 (2)

The side effects were acceptable        6 (4)       3 (2)     13 (8)

The time awaiting till the abortion     4 (2)       5 (3)     12 (7)
was complete was acceptable

Using misoprostol at home               4 (3)       2 (1)     11 (7)
was acceptable.

I would recommend this procedure        7 (4)       2 (1)     13 (8)
over a surgical abortion to other
pregnant women seeking an early
abortion.

If I needed another abortion,           7 (4)       2 (1)     13 (8)
I would choose this procedure
over a surgical abortion.

                                             Choices on Scale

                                     Strongly
                                       Agree,    Agree,    Average
Statement                              n (%)     n (%)      Score

Overall, the procedure went well.     49 (30)   110 (66)     4.6

The cramping pain was acceptable.     68 (41)    58 (34)     3.9

The bleeding was acceptable           88 (53)    70 (42)     4.3

The side effects were acceptable      61 (37)    83 (50)     4.3

The time awaiting till the abortion   62 (38)    82 (50)     4.3
was complete was acceptable

Using misoprostol at home             47 (29)    99 (61)     4.4
was acceptable.

I would recommend this procedure      29 (18)   115 (69)     4.5
over a surgical abortion to other
pregnant women seeking an early
abortion.

If I needed another abortion,         29 (18)   115 (69)     4.5
I would choose this procedure
over a surgical abortion.