Medical; Abortion, Fetus
Conditions
Keywords
medical abortion, telephone follow-up, ultrasound, serum hCG, methotrexate, misoprostol
Brief summary
Background: Medical abortions in Canada are provided using a standard regimen of methotrexate and misoprostol. After these medications are administered, patients are most commonly checked for termination of the pregnancy with an ultrasound and physical examination at an in-clinic follow-up appointment. These follow-up appointments can be inconvenient, costly, and take away from patient privacy. Furthermore, it has been suggested that these follow-up appointments may not be necessary for patients. Objective: To determine whether remote follow-up, using telephone and blood testing is a feasible, safe, and effective method of follow-up after medical abortion, compared to standard care that requires an in-clinic visit and ultrasound. This study offers women the option of remote follow-up by telephone combined with serum Beta-human chorionic gonadotropin (β-hCG) testing or standard in-clinic follow up. We will determine women's preferences for follow up, and compare adherence to the follow-up schedule, number of clinical contacts, and outcomes of the abortion. This study will be performed at two clinics in Toronto, the Bay Centre for Birth Control (BCBC) and the Choice in Health Clinic (CIHC). Primary Hypothesis: Follow-up will be more successful with RFU, compared to SFU.
Detailed description
The protocol is altered for women who have an ultrasound that shows only a gestational sac (no yolk sac or fetal pole). Women in both follow-up groups will have β-hCG testing on the day of methotrexate injection and again in 8 days. If the level does not fall by 50% or they have concerning symptoms, they are asked to return to clinic for evaluation. If the β-hCG level falls by 50% or more, they will continue to be followed as per the protocol in their chosen group, but will be followed until their β-hCG becomes negative.
Interventions
OTHERRemote Follow-up (RFU)
Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.
OTHERStandard Follow-up (SFU)
Study Day 15 (± 3 days)requires an in-person post-abortion checkup: transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion.
Sponsors
Women's College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Requests a medical abortion and fulfills standard eligibility criteria for M&M abortion: * Clear decision to have an abortion * Valid Ontario Health card * Willing to abstain for vaginal intercourse and alcohol for 14 days * Ability to insert misoprostol vaginal tablets * Emergency Contact number * Stop folic acid vitamins on initial contact * Good general health * Single intrauterine gestation less than or equal to 49 days as determined by transvaginal ultrasound * Telephone access * Access to emergency medical care within 30 minutes of home * Agrees to undergo a surgical abortion in case of failure of the medical abortion method 2. Ability to understand the protocol and consent 3. Willingness to comply with either the SFU or RFU follow-up schedule
Exclusion criteria
1. Factors that exclude women from eligibility for M&M abortion: * Coagulopathy or hemoglobin less than 100, White Blood Cell count \< 4.0 platelet \<140,000 * Allergy to methotrexate or misoprostol * Presence of an intrauterine device * Acute or chronic renal or hepatic disease * Acute inflammatory bowel disease * Uncontrolled seizure disorder * Sickle cell anemia * Breastfeeding * Chronic oral corticosteroid therapy * Any condition that in the opinion of the clinician investigator would compromise the safety of medical abortion for this patient 2. Requires the support of an interpreter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful follow-up in women choosing RFU compared with those choosing SFU after medical abortion with M&M | Within the designated time of 15 days post methotrexate injection ±3 days | Successful follow-up will be defined as completion of telephone follow-up contact and serum β-hCG testing (for the RFU cohort) or attendance for the in-clinic follow-up visit within the designated time of 15 days post methotrexate injection ±3 days (for the SFU cohort). |
Secondary
| Measure | Time frame |
|---|---|
| Percent of women who choose RFU | 1 day |
| Percent of women choosing RFU who complete follow-up without a clinic visit | Within the designated time of 15 days post methotrexate injection ±3 days |
| Percent of women in RFU and SFU groups who made no unscheduled visits related to medical abortion | Within 28 days of methotrexate injection ±3 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of SFU and RFU | At 28 days after methotrexate injection ±3 days | Measured using an Acceptability Questionnaire administered at discharge from ongoing care. This questionnaire is adapted from a previous study of acceptability of mifepristone and misoprostol abortions by Winikoff et al. It contains four close-ended and three open-ended questions designed to capture the patient's perspective on their medical abortion experience, whether they would choose the same method of follow-up in future, and their opinions on the best and worst features of their chosen follow-up method. |
| Number of subject-initiated telephone contacts during clinic hours | Within 28 days of methotrexate injection ±3 days | Abstracted from the medical record |
| Number of subject-initiated telephone contacts to on-call physician | Within 28 days of methotrexate injection ±3 days | Abstracted from the medical record |
| Emergency department visit | Within 28 days of methotrexate injection ±3 days | Determined through subject history |
| Number of letters sent | Within 28 days of methotrexate injection ±3 days | Abstracted from the medical record |
| Selected method of contraception | At 28 days after methotrexate injection ±3 days | — |
| Reason for choice of follow-up method | 1 day | — |
| Number of clinic-initiated telephone contacts outside of the scheduled follow-up contact for the RFU group | Within 28 days of methotrexate injection ±3 days | Abstracted from the medical record |
| Hemorrhage - defined as bleeding resulting in transfusion, intravenous fluids or a drop in hemoglobin of 20 g | Within 28 days of methotrexate injection ±3 days | Determined from patient history with retrieval of emergency department/hospital records or documented drop of 20 g. |
| D&C with the cause characterized as 1) for bleeding, at clinician's recommendation, 2) for continuing pregnancy, 3) at patient's request (usually because of delayed expulsion of the pregnancy in a medically stable patient) | Within 35 days of methotrexate injection | — |
| Infection requiring antibiotics | Within 28 days of methotrexate injection ±3 days | Determined from the clinic record or subject history |
Countries
Canada
Outcome results
None listed