Comparison of Telephone Follow-up With In-person Follow-up After Medical Abortion

Medical; Abortion, Fetus Clinical Trial

Official title:

A Comparison of Remote Follow-up After Medical Abortion Using Telephone and Serum Pregnancy Testing With Standard In-person Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943279
• Other study ID #: DUNNS-AFPFY112-RFUMA
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: December 8, 2014
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medical; Abortion, Fetus

Intervention

Other:
• Remote Follow-up (RFU)
Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.
• Standard 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.

Locations

Country	Name	City	State
Canada	Choice in Health Clinic	Toronto	Ontario
Canada	Women's College Hospital-Bay Center for Birth Control	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Clark W, Bracken H, Tanenhaus J, Schweikert S, Lichtenberg ES, Winikoff B. Alternatives to a routine follow-up visit for early medical abortion. Obstet Gynecol. 2010 Feb;115(2 Pt 1):264-72. doi: 10.1097/AOG.0b013e3181c996f3. — View Citation

Clark W, Panton T, Hann L, Gold M. Medication abortion employing routine sequential measurements of serum hCG and sonography only when indicated. Contraception. 2007 Feb;75(2):131-5. Epub 2006 Dec 22. — View Citation

Creinin MD, Vittinghoff E, Keder L, Darney PD, Tiller G. Methotrexate and misoprostol for early abortion: a multicenter trial. I. Safety and efficacy. Contraception. 1996 Jun;53(6):321-7. — View Citation

Fiala C, Safar P, Bygdeman M, Gemzell-Danielsson K. Verifying the effectiveness of medical abortion; ultrasound versus hCG testing. Eur J Obstet Gynecol Reprod Biol. 2003 Aug 15;109(2):190-5. — View Citation

Kaneshiro B, Edelman A, Sneeringer RK, Ponce de Leon RG. Expanding medical abortion: can medical abortion be effectively provided without the routine use of ultrasound? Contraception. 2011 Mar;83(3):194-201. doi: 10.1016/j.contraception.2010.07.023. Epub 2010 Sep 17. Review. — View Citation

Perriera LK, Reeves MF, Chen BA, Hohmann HL, Hayes J, Creinin MD. Feasibility of telephone follow-up after medical abortion. Contraception. 2010 Feb;81(2):143-9. doi: 10.1016/j.contraception.2009.08.008. Epub 2009 Sep 30. — View Citation

Rossi B, Creinin MD, Meyn LA. Ability of the clinician and patient to predict the outcome of mifepristone and misoprostol medical abortion. Contraception. 2004 Oct;70(4):313-7. — View Citation

Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception. 2001 Aug;64(2):81-5. — View Citation

von Hertzen H, Honkanen H, Piaggio G, Bartfai G, Erdenetungalag R, Gemzell-Danielsson K, Gopalan S, Horga M, Jerve F, Mittal S, Ngoc NT, Peregoudov A, Prasad RN, Pretnar-Darovec A, Shah RS, Song S, Tang OS, Wu SC; WHO Research Group on Post-Ovulatory Methods for Fertility Regulation. WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy. BJOG. 2003 Sep;110(9):808-18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emergency department visit	Determined through subject history	Within 28 days of methotrexate injection ±3 days	Yes
Other	Hemorrhage - defined as bleeding resulting in transfusion, intravenous fluids or a drop in hemoglobin of 20 g	Determined from patient history with retrieval of emergency department/hospital records or documented drop of 20 g.	Within 28 days of methotrexate injection ±3 days	Yes
Other	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	No
Other	Infection requiring antibiotics	Determined from the clinic record or subject history	Within 28 days of methotrexate injection ±3 days	Yes
Other	Acceptability of SFU and RFU	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.	At 28 days after methotrexate injection ±3 days	No
Other	Number of subject-initiated telephone contacts during clinic hours	Abstracted from the medical record	Within 28 days of methotrexate injection ±3 days	No
Other	Number of subject-initiated telephone contacts to on-call physician	Abstracted from the medical record	Within 28 days of methotrexate injection ±3 days	No
Other	Number of clinic-initiated telephone contacts outside of the scheduled follow-up contact for the RFU group	Abstracted from the medical record	Within 28 days of methotrexate injection ±3 days	No
Other	Number of letters sent	Abstracted from the medical record	Within 28 days of methotrexate injection ±3 days	No
Other	Selected method of contraception		At 28 days after methotrexate injection ±3 days	No
Other	Reason for choice of follow-up method		1 day	No
Primary	Rate of successful follow-up in women choosing RFU compared with those choosing SFU after medical abortion with M&M	Successful follow-up will be defined as completion of telephone follow-up contact and serum ß-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).	Within the designated time of 15 days post methotrexate injection ±3 days	No
Secondary	Percent of women who choose RFU		1 day	No
Secondary	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	No
Secondary	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	No