Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial.

OBJECTIVE: To investigate phone follow-up with a semiquantitative urine pregnancy test and symptom checklist as a replacement for universal clinic follow-up after medical abortion. METHODS: One thousand four hundred thirty-three women seeking early medical abortion at four hospitals in Vietnam were randomized to clinic or phone follow-up. Women allocated to clinic follow-up returned to the hospital for confirmation of abortion outcome 2 weeks after mifepristone administration. Women assigned to phone follow-up completed a semiquantitative pregnancy test at initial visit to determine baseline human chorionic gonadotropin range and again at home 2 weeks later. Clinic staff called women to review the pregnancy test results and symptom checklist. Women who screened positive were referred to the clinic. Effectiveness, feasibility, and acceptability of the follow-up methods were assessed. RESULTS: The rate of ongoing pregnancy was not significantly different between the two groups (clinic: 2.7% phone, 2.5%, relative risk 0.9, 95% confidence interval 0.99-1.02). Eighty-five percent of women in the phone group did not need an additional clinic visit. Phone follow-up was highly effective in screening for ongoing pregnancy with a sensitivity and specificity of 92.8% and 90.6%, respectively. Specificity of the pregnancy test alone (eg, without the symptom checklist) was higher (95.7%). CONCLUSION: Phone follow-up offers a feasible and effective approach to identify women with ongoing pregnancy after early medical abortion. When used with the semiquantitative pregnancy test, the symptom checklist offered no additional benefit and decreased the specificity of the screening. Given its effectiveness and ease of use, the semiquantitative pregnancy test alone could replace routine clinic follow-up after early medical abortion. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01150422. LEVEL OF EVIDENCE: I.

Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up.

OBJECTIVE: To simplify follow-up after medical abortion by examining whether women could use a semi-quantitative pregnancy test at home to screen for ongoing pregnancy. METHODS: Three hundred women seeking medical abortion at a tertiary hospital in Vietnam participated in the study. Participants used a semi-quantitative pregnancy test at the hospital to estimate baseline human chorionic gonadotropin (hCG) levels and administered another test at home 2 weeks later for comparison. Women interpreted the test result at home and then returned to hospital for follow-up care. At this visit, self-assessment was verified. To assess further the feasibility of the test as a follow-up tool in service delivery, 200 additional women completed a user comprehension survey. RESULTS: The tests identified all 11 ongoing pregnancies among study participants (100% sensitivity; 89.7% specificity). Women reported that the test was easy to use (255/292 [87.3%]) and that provider instructions helped them to use the test (291/292 [99.7%]). CONCLUSION: Semi-quantitative pregnancy tests offer high sensitivity and negative predictive value. If user instructions can be further simplified, the tests could be used in lieu of transvaginal ultrasound and/or serum hCG at clinic-based follow-up or by women themselves for home-based follow-up. Clinical trials.gov:NCT01150279.

Can at-home semi-quantitative pregnancy tests serve as a replacement for clinical follow-up of medical abortion? A US study.

BACKGROUND: Medical abortion in the United States requires clinic-based follow-up, representing additional time and cost to women and clinics. We studied a semi-quantitative home pregnancy test as a possible replacement for in-person follow-up. STUDY DESIGN: Four hundred and ninety women participated in the clinical study and used a pregnancy test to determine baseline human chorionic gonadotropin (hCG) on the day of mifepristone administration and follow-up hCG 1 week later. One hundred and eighty-nine other women completed a user comprehension survey. Accuracy, feasibility and acceptability of the test were assessed in both the clinical study and the survey. RESULTS: The test identified the one ongoing pregnancy in the clinical study cohort. Sensitivity and specificity were calculated at 100.0% and 97.0%. The majority of participants in both the clinical study and the user comprehension survey found the test to be "very easy" or "easy" to use. CONCLUSION: At-home follow-up with a semi-quantitative pregnancy test is feasible for service delivery in the United States.

Community-based provision of injectable contraceptives in Madagascar: 'task shifting' to expand access to injectable contraceptives.

INTRODUCTION: Injectable contraceptives are now the most popular contraceptive methods in sub-Saharan Africa. Injectables have not been an option for African women lacking convenient access to health facilities, however, since very few family planning programmes permit community-based distribution (CBD) of injectables by non-medically trained workers. Committed to reducing unmet contraceptive need among remote, rural populations, the Ministry of Health and Family Planning (MOHFP) of Madagascar sought evidence regarding the safety, effectiveness and acceptability of CBD of injectables. METHODS: The MOHFP joined implementing partners in training 61 experienced CBD agents from 13 communities in provision of injectables. Management mechanisms for injectables were added to the CBD programme's pre-existing systems for record keeping, commodity management and supervision. After 7 months of service provision, an evaluation team reviewed service records and interviewed CBD workers and their supervisors and clients. RESULTS: CBD workers demonstrated competence in injection technique, counselling and management of clients' re-injection schedule. CBD of injectables appeared to increase contraceptive use, with 1662 women accepting injectables from a CBD worker. Of these, 41% were new family planning users. All CBD agents wished to continue providing this service, and most supervisors indicated the programme should continue. Nearly all clients interviewed said they intended to return to the CBD worker for re-injection and would recommend this service to a friend. CONCLUSIONS: This experience from Madagascar is among the first evidence from sub-Saharan Africa documenting the feasibility, effectiveness and acceptability of CBD services for injectable contraceptives. This evidence influenced national and global policy makers to recommend expansion of the practice. CBD of injectables is an example of effective task shifting of a clinical practice as a means of extending services to underserved populations without further burdening clinicians.