Abortion, Induced Clinical Trial
Official title:
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive
mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete
abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within
each gestational age group.
This is a prospective clinical trial. Women will be enrolled such that 40 women are in each
of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment
is initiated. Once a gestational age range includes 40 subjects, enrollment in that group
will be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg
misoprostol tablets between the check and gum (2 tablets on each side). The women will be
instructed to keep the tablets in place for 30 minutes; any remaining portions of the
tablets will be swallowed after this time. Participants will follow-up 24 hours after
receiving the misoprostol. Vaginal ultrasonography will be performed to assess for expulsion
of the gestational sac. Women who have not aborted by the first follow-up visit will be
given a dose of vaginal misoprostol and will return for a follow-up visit in one week.
Subjects who have not aborted by the two-week follow-up will be offered a surgical abortion.
At each visit, data will be collected on bleeding, cramping, other side effects, and
medication use.
1. TELEPHONE SCREEN:
Initial contact will be by a phone call (or, rarely, a drop-in visit) initiated by a
potential study participant. A member of the research staff will advise the potential
participant of the study rationale, protocol, risks, benefits, and visit schedule. We
request a waiver of the requirement to obtain signed informed consent for the screening
process, which will usually take place over the phone. We believe we meet the criteria
for the use of this waiver because the screening procedure presents no more than
minimal risk of harm to the subjects and involves no procedures for which written
consent is normally required outside of the research context. The information obtained
during the screening phone call is the same type of information that would be collected
on patients setting up an appointment for an abortion. The telephone script and screen
are included in Attachment 2. If the subject does not meet inclusion criteria, the
information collected during the screening process will be destroyed. Potential
subjects interested in participation will be scheduled for a screening visit.
Each subject will undergo a minimum of 3 visits all of which will be performed in the
Family Planning Research Office at Magee-Womens Hospital. She will also receive a
minimum of 3 follow-up telephone calls. Those subjects who do not pass the pregnancy by
the first follow-up visit will be scheduled for return visits as indicated on the Study
Flow Sheet (see attachment) and described below.
2. SCREENING AND ENROLLMENT: Visit length 1 ½ hours.
1. After obtaining consent for a screening ultrasound evaluation, a transvaginal and
a transabdominal ultrasound examination will be performed to ascertain gestational
age. The transvaginal ultrasound results will be used to confirm gestational age
and document an intrauterine gestation for the study protocol. Vaginal ultrasound
to confirm estimated gestational age (EGA) will use the following criteria:
- EGA (days) = mean sac diameter + 3025
- EGA (days) = embryonic pole + 4226
- Mean sac diameter ([length + width + depth]/3) should be used only when no
embryonic pole is present.
- If the ultrasound EGA is different from LMP EGA by 4 days or more, then the
ultrasound EGA should be used as the study EGA.
2. Written informed consent will be obtained at the screening visit prior to any
research activities. The investigator or one of the co-investigators, who are
physicians, will sign the informed consent document.
3. After obtaining informed consent, a medical history and initial laboratory tests
(hemoglobin and blood type) will be obtained. If the pelvic examination is normal,
the endovaginal ultrasound confirms that the gestational age will be less than 63
days on the day of the mifepristone administration, and the laboratory tests
satisfy the entry criteria, the subject will be asked to participate in the study.
4. A HIPAA compliant “Release of Medical Records” form will be signed to allow future
access to medical records related to any care provided during the study by another
health care provider.
3. VISIT 1: The subject will return prior to reaching 64 days gestation. This day will be
considered Study Day 1. Visit length 30 minutes.
1. The research staff will administer a pre-study questionnaire. The subject will
complete a Visual Analogue Scale (VAS) assessment.
2. Eligibility criteria will be reviewed and, if indicated by a history of bleeding
since screening, a vaginal ultrasound will be performed.
3. A licensed clinician will distribute the medications after completion of the
questionnaire. The medications will be kept in a locked file in the research
office and a log will be generated to track medication usage, lot numbers, and
expiration dates. All subjects will take the mifepristone and misoprostol in front
of the research clinician.
- She will receive mifepristone 200 mg orally and swallow the tablet in front
of one of the researchers. THE SUBJECT CANNOT RECEIVE THE MIFEPRISTONE UNTIL
A MINIMUM OF 24 HOURS AFTER COMPLETION OF THE INFORMED CONSENT.
- Within 5 minutes of mifepristone administration, the subject will be given
four 200 µg tablets of misoprostol to place between the cheek and gum (2 on
each side) and to allow them to remain in that location for 30 minutes. After
this time lapse, any remaining tablets will be swallowed. The subject will
not need to wait in the office during the 30 minutes.
4. The subject will receive a prescription for codeine (30 mg) or hydrocodone (5 mg),
#20 and an instruction sheet with the phone numbers to call if she has any
questions or problems.
5. Rh-immune globulin will be administered if she is Rh-negative.
6. The subject will be scheduled for follow-up 24 ± 1 hours after administration of
the misoprostol.
4. VISIT 2: 24 ± 1 hours after misoprostol administration. Visit length 1 hour.
1. Endovaginal and abdominal ultrasound examinations will be performed.
- If the vaginal ultrasound examination demonstrates a gestational sac, the
subject will receive a “rescue” dose of vaginal misoprostol (four 200 µg
tablets of misoprostol), which will be placed by the clinician. A follow-up
appointment will be scheduled for study Day 15 (range Day 13-17)
- If the vaginal ultrasound does not demonstrate a sac the abortion will be
considered complete and telephone follow-up contacts will be the only
scheduled evaluations from this point forward.
2. All subjects will complete a post-study VAS, which will take about 5 minutes to
complete.
5. TELEPHONE FOLLOW-UP #1: Study Day 8 (range Day 6-10). Call length 10 minutes. Subjects
will be contacted to assess their clinical status including bleeding, cramping, and
medication requirements. If necessary, based on the subject’s responses, appointments
for evaluation by a clinician will be made at that time.
6. VISIT 3/TELEPHONE FOLLOW-UP #2: Study Day 15 (range Day 13-17). Visit length (if
required) 1 hour, call length 10 minutes)
1. Subjects who had expelled the gestational sac as based on prior ultrasound
examination will receive telephone follow-up to assess their clinical status.
Appointments for evaluation by a clinician will be made as necessary. A post-study
acceptability questionnaire will be performed with these subjects over the
telephone, which will take about 5 minutes to complete.
2. Subjects who had not expelled the gestational sac on prior examination will return
to the office for this visit. Endovaginal and abdominal ultrasounds will be
performed.
- If the vaginal ultrasound shows an intrauterine gestation with embryonic
cardiac activity, the subject will be offered and advised to have a surgical
abortion to be done as soon as possible. After the D&C, the subject will
complete a 5-minute post-study acceptability questionnaire. She will also
have a telephone follow-up on Study Day 36.
- If the vaginal ultrasound shows the gestational sac to be present without
embryonic cardiac activity, the subject may have a D&C and complete the
acceptability questionnaire or can pursue expectant management and return on
Study Day 36 (range Day 32-40).
- If the vaginal ultrasound demonstrates absence of the gestational sac, she
will complete a post-study acceptability questionnaire at the end of her
visit which will take about 5 minutes to complete and all further follow up
will be performed by telephone.
7. VISIT 4/TELEPHONE FOLLOW_UP #3: Study Day 36 (range Day 32-40). Visit length (if
required) 30 minutes-1 hour, call length 10 minutes.
1. Subjects who had expelled the gestational sac as based on prior ultrasound
examination or who had a D&C will receive telephone follow-up to assess their
clinical status. Appointments to be evaluated by a clinical will be made as
necessary.
2. If the subject must return for this visit, endovaginal and abdominal ultrasound
examinations will be performed. If the vaginal ultrasound shows the gestational
sac to still be present, the patient will be offered a surgical abortion.
3. At the completion of the surgical abortion or if the ultrasound demonstrates
absence of a sac, a 5-minute post-study acceptability questionnaire will be
performed.
8. OTHER
1. The subject will be questioned at each visit regarding side effects experienced
from the medications, bleeding and cramping, pain medication required, and other
medications used since the last visit.
2. If the subject does not return for a scheduled visit, she should be telephoned to
reschedule the visit. If the patient is unable to return for her follow-up, the
required information regarding bleeding history, medications, medication side
effects, and questionnaire answers can be obtained over the phone. If the subject
is unable to be reached by phone within two weeks of her scheduled visit, a
certified letter must be sent indicating her need to return. Subjects will be
considered lost to follow-up only if the final visit is not completed by the time
the study is closed.
3. If the subject fails to return for her Visit 2, but returns at some later time
during her study participation period and is found to have a retained gestational
sac or continuing pregnancy on ultrasound, she may receive an additional vaginal
dose of misoprostol (4 tablets; up to Study Day 12) or be offered a D&C (at any
time).
4. The subject will be counseled not have intercourse or drink alcohol until the
completion of the abortion is confirmed.
5. Contraceptive counseling will be performed throughout the study. A method of
contraception should be instituted after the abortion has occurred and before the
subject resumes sexual activity.
6. Endovaginal ultrasound may be performed at any time other than what is required by
the protocol if felt to be necessary by the clinician.
7. Standard suction curettage will be performed for continuing pregnancy at visit 3
or persistent sac at visit 4, uterine hemorrhage, or incomplete abortion.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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