This study was a randomized controlled non-inferiority trial with an additional 3-month cross-sectional follow-up interview with a sub-set of women from the RCT. The RCT compared clinic follow-up with home-assessment at 2 weeks after early medical abortion in a low-resource setting in Rajasthan, India. The 3-month follow-up was carried out to monitor the use and continuation of methods, and to determine whether different trends of contraceptive use could be established in the two study groups. The RCT followed CONSORT guideline format for non-inferiority randomised trials . The primary outcome of the RCT was to measure the efficacy of home-assessment of women’s abortion outcome. Contraceptive use was measured as a secondary outcome of the RCT and the primary outcome of the cross-sectional sub-study. Details of the RCT implementation, setting and context, in addition to the methods, are described in the study protocol . Results related to the efficacy of simplified follow-up after medical abortion are reported elsewhere .
Study setting and participants
The RCT was conducted at six primary health care facilities; three clinics situated in an interior rural area in the Araveli mountain range, characterized by limited road connections, poverty, and strong gender disparities; and three clinics in Udaipur City. The rural clinics cater to women belonging to a lower socio-economic stratum and the area is largely populated by social groups that are referred to as marginalized  and defined by the government as scheduled castes (SC) and scheduled tribes (ST). The urban clinics cater mainly to urban women from all socio-economic strata. Women were eligible to participate in the study: when seeking medical abortion; with a pregnancy of up to 9 weeks of gestation, as estimated by pelvic examination; if they resided in an area where follow-up was possible or had a phone of their own; and if they agreed to a follow-up appointment 2 weeks after the abortion. For the 3-month follow-up, women were included if they: owned a phone; were recruited in the urban study sites; and agreed to a telephonic follow-up at 3 months. Women with known contraindications to medical abortion; who had a haemoglobin value below 85 mg/l; or who were below 18 years of age were excluded.
Intervention and procedure
Before study recruitment, a doctor assessed all women seeking abortion and identified the women who were eligible, and who had opted for a medical abortion. These women were counselled with regard to the abortion procedure and were subsequently administered the first dose, mifepristone (200 mg), in the clinic. All women were counselled on contraception according to clinical standard procedure in respective study site. Additionally, the doctor and woman agreed on the location of misoprostol administration together; this was not randomized, but was based on the woman’s preference and the doctor’s discretion. Subsequently, the women who had been identified by the doctor as being clinically eligible for the study met with a research assistant, who explained the study and obtained informed consent. Women who consented were randomly allocated to either return to the clinic for follow-up by a doctor (in-clinic follow-up group), or to assess their abortion outcome at home using an LSPT and a pictorial instruction sheet, and subsequently be followed-up by a research assistant over the telephone or at home (home-assessment group). Research assistants recorded the women’s socio-demographic profile and reproductive history, including previous use of contraception. Scheduled follow-up took place at 10–15 days after mifepristone administration. Women were informed that they could return to the clinic in case of any perceived complications, however, the women in the home-assessment group were advised to not return to the clinic for the purpose of contraception before their scheduled follow-up. This stipulation was made because interim visits would interfere with the home-assessment intervention, unless they were returning to the clinic due to complications or adverse events. The study sites were instructed to provide contraceptive counselling to all women, and to provide a suitable method, when applicable, on day 1 and day 3 (for the women who returned to the clinic for misoprostol administration (n = 333)) of the medical abortion. The women who returned to the clinic for misoprostol administration on day three met a doctor or a nurse and stayed in the clinic for 1–4 h depending on the study site and the distance to the woman’s home. On this day, the care provider completed the research questionnaire and recorded whether or not a contraceptive method was provided and, if so, which method was provided. However, no specific intervention or training in contraceptive counselling for the purpose of the study was given and when implementing and piloting the intervention we realised that providers at the study sites were reluctant to provide injectables already on day 1 or 3 due to fear of side-effects and increased bleeding post-abortion. Most providers preferred to provide the method at the time of follow-up, regardless of our attempts to encourage them to provide the method earlier. A maximum of three follow-up attempts were made within 1 month after the abortion, and women not found were considered lost to scheduled follow-up. However, these women were contacted retrospectively to confirm their abortion outcome.
A doctor or a midwife assessed women in the clinic follow-up group at follow-up, 10–15 days after mifepristone administration and provided contraception upon request. All women who returned to the clinic for follow-up were reimbursed for their travel expenses. The women in the home-assessment group were followed-up by a research assistant over the telephone or at home when the woman did not have a phone of her own, commonly the case among rural residents. Women were asked about their LSPT result and pregnancy symptoms. Additionally, the research assistant asked all women questions relating to contraceptive preference, use and intention, as well as about their abortion experience.
At the 2-week follow-up, women recruited to the study in the urban sites, and who owned a phone of their own, were asked to participate in the 3-month follow-up interview. Women in the rural sites were not considered for the 3-month cross-sectional survey due to their lack of mobile phones and because it was not considered feasible or appropriate to make another home-visit. Three months after their abortion, the same research assistant who met the women at 2 weeks telephoned the women who had agreed to a follow-up appointment. A maximum of three attempts were made before the women were considered lost to the 3-month follow-up. Questions regarding contraceptive use, method of initiation and time of initiation were asked. To facilitate a method for the women to remember their time of contraceptive initiation we asked whether contraception was initiated: immediately on day 1of the abortion; after misoprostol on day 3; at the time of the follow-up (2 weeks); at the time of the following menstruation (around 4 weeks); recently, which refers to 1 month previous to the 3-month follow-up (8 weeks); just now (12 weeks); or not at all. We also asked whether the woman had had any pregnancies or abortions in the last 3 months. Standardized questionnaires were used throughout the study.
The study sites offered copper-IUD, 3-month injection, oral pill and condom, which are referred to as modern contraception for the purpose of this study. In the results section, the reversible contraceptive methods are grouped into two groups: the injectable and copper-IUD as one group, and the oral pill and condom as another group. This is an attempt to categorise the methods according to: methods with a more ‘long-acting and user-independent nature’, although the injection is not considered a LARC by the WHO; and methods with a more ‘short-acting and user-dependent nature’. Additionally, in contrast to IUD and injectables, women who reported initiation of contraceptive pills or condoms at the 2-week follow-up, may or may not actually use these methods after administration, especially with regard to condom use. Contraceptive use was defined as current use or initiation at 2 weeks and 3 months. Contraceptive initiation refers to the time when women started using their contraception. Additionally, we asked questions regarding; contraceptive method of preference, and the intention to initiate the method preferred at 2 weeks or the reasons for not choosing a method. Women could select several methods of preference, however for the purpose of analysis of method preference and contraceptive counselling (Fig. 4), we chose to organise methods of preference accordingly: women, who preferred either injectable or IUD have been reported as preferring injectable or IUD regardless of any additional preferences. Women, who reported to prefer oral pill only responded oral pill or condom; women, who reported to prefer sterilization only responded sterilization or condom; and women, who reported to prefer condom responded no other method but condom. Intention to initiate was divided into two categories: ‘actual plan’, defined as today, this week, after recovered from abortion, and after next menses; and ‘no actual plan’, defined as when my husband moves back from the city, after next holiday, and sometime next year.
Study outcomes and measures
The primary outcome of this study was women’s use of modern contraception post-abortion, compared between study groups, and measured at 2 weeks and at 3 months after the medical abortion. Due to the small sample size of women in the 3-month follow-up, these data were used to indicate a trend of overall contraceptive use and continuation. The contraceptive preference, choice and usage patterns at 2 weeks in the sub-set of women allowed us to compare patterns seen among the same women in the 3-month follow-up, and in that way validate the 3-month data considering the small sample size at the follow-up. Moreover, it allowed us to compare the contraceptive patterns found in the sub-set of women with the patterns in the total study population at 2 weeks and hence indicate a trend of overall contraceptive use at 3 months, while being aware of the socio-economic differences between the sub-sample population and the whole study population. Secondary outcomes included: women’s preferred contraceptive method; whether women had initiated their preferred method at the time of follow-up (2 weeks and 3 months); and if not, whether their intentions to initiate were according to an ‘actual plan’ or ‘no actual plan’ (as defined above). Moreover, associations between contraceptive use at 2 weeks and 3 months; and women’s socio-demographic and reproductive background; contraceptive counselling; time of provision of the contraceptive method; contraceptive intention at 2 weeks; and abortion experience in terms of satisfaction, were assessed.
Randomisation and masking
Block randomisation, using blocks of six, was used and a computerised random number generator (Random Allocation Software 2.0) generated the randomisation list . The staff who generated the list and prepared the opaque sealed envelopes used for randomisation were not involved in data collection. Details of the randomisation procedure are recorded in the study protocol .
Statistical methods and analysis
All statistical calculations were made using SPSS (version 20) and R (version 3.0.3). Descriptive statistics are presented for all variables. Categorical variables are compared using χ2-test or Fisher’s exact test when appropriate. Continuous data are presented as mean (range). A p-value below 0.05 and a 95 % confidence interval (95 % CI), presented as ±, demonstrate significant differences. Odds ratios (ORs) were derived using logistic regression with various explanatory variables. Where related ORs were significant, adjusted odds ratios (AORs) were derived with multivariate logistic regression. Use of contraception over time was illustrated by conducting Kaplan-Meier survival analysis where a log-rank test established significance.
Analyses were carried out for evaluable subjects (ES): all women with a successful scheduled follow-up at 2 weeks, regardless of whether their abortion was complete or whether they had taken the full course of the medical abortion or not. To compensate for difference in loss to scheduled follow-up between the study groups, the outcome of whether a woman had initiated contraception was analysed using intention to treat (ITT) analysis, including all women who were randomized to one of the study groups, assuming that none of the women who were lost to scheduled follow-up had initiated a method at 2 weeks, except where data for contraceptive provision on day three were available. All women who had a successful 3-month follow-up were included in the sub-set analysis.
The study was developed and coordinated by Karolinska Institutet, and Uppsala University, Sweden, and Action Research and Training for Health (ARTH), Udaipur, India. The trial was registered at Clinicaltrials.gov: NCT01827995. The Institutional Ethics Committees at ARTH, and the Health Ministry’s Steering Committee of Government of India approved the study.