Self-administered Follow-up Using a Low-sensitivity Pregnancy Test after Medical Abortion: Results of a Partially Randomized Patient Preference Trial

Abstract

Introduction

In Germany, follow-up after medical abortion is typically conducted via ultrasound examination. International evidence suggests that self-administered follow-up using low-sensitivity pregnancy tests may be a safe and acceptable alternative. This study assessed the effectiveness and acceptability of this approach within the German healthcare system.

Methods

In this prospective, multicenter, partially randomized, patient preference study conducted in 11 German centers (March–September 2024) involving 312 women, participants with strong preferences could choose their preferred follow-up method, while all others were randomized to either self-testing or ultrasound follow-up. Follow-up was performed using a low-sensitivity pregnancy test (1000 mIU/ml) at home or by ultrasound examination in the clinic. The primary outcome was the detection of ongoing pregnancies; patient satisfaction was assessed as a secondary outcome.

Results

The detection rate of ongoing pregnancies was 100% in both groups. Specificity was 92.7% in the self-testing group and 100% in the ultrasound group. Complications were rare and occurred at similar rates in both groups. Discordant cases were rare and mainly represented false-positive results with faint test lines near the cut-off; severe complications did not occur more frequently. Satisfaction with the follow-up method was slightly lower in the self-testing group (85.9%) compared to the ultrasound group (98.3%) but remained within an acceptable range. Subjective feelings of safety were high in both groups.

Conclusion

Self-administered follow-up using a low-sensitivity pregnancy test is a safe and well-accepted alternative to ultrasound examination after medical abortion. It may improve access to follow-up care, particularly for women living in underserved or remote areas.

Keywords

outpatient care - medical abortion - follow-up care - low-sensitivity pregnancy test - patient satisfaction

Introduction

Medically induced abortion is increasingly being used as the method of choice for abortion in Germany [1]. According to data from Destatis, fewer than 10% of abortions were medically induced at the beginning of the 2000s [2]. Although the total number of abortions between 2014 (99715) and 2024 (106455) has remained almost unchanged, the percentage of abortions which were induced medically has increased significantly over the same period, rising by 24.5 percentage points to 45.4% [1] [3]. This development underlines the importance of low-threshold, patient-centered, follow-up methods. Follow-up in Germany is mostly done by ultrasound examination carried out by a physician [4] [5]. International guidelines recommend the administration of low-sensitivity pregnancy tests (LSPT) for at-home self-monitoring as a safe and accepted alternative [6] [7] [8] [9] [10] [11]. The current German S2k-guideline on abortion also explicitly states that follow-up may be done with an LSPT [12]. Nevertheless, this method is still rarely used in Germany. Especially for patients with limited access to medical care – for example, patients facing long travel times due to a lack of healthcare facilities closer to home – LSPT could be a low-threshold alternative which would reduce access problems [13] [14] [15] [16] [17]. The aim of this study was to investigate the effectiveness and acceptance of LSPT under everyday conditions in the context of the German healthcare system.

Methods

Study design and conduct

This prospective, multicenter, partially randomized patient preference trial (PRPPT) was carried out in 11 medical practices/clinics in Germany from March to September 2024. The study design combines randomized allocation with the option of patients exercising their right to choose and is especially suitable for studies where patients are expected to have strong preferences. The aim is to reconcile the internal validity of a randomized study design with the external validity of realistic decision-making processes [18] [19].

All consecutive patients with planned medically induced abortion (MAB) were identified between March 1st and September 30th, 2024 in 11 participating centers. Inclusion criteria were full legal age (≥ 18 years), planned MAB, capacity to consent, and the ability to carry out a urine test at home after receiving written instructions. Exclusion criteria were insufficient knowledge of German, not yet of legal age, and suspected extrauterine pregnancy. Patients were approached and informed by trained physicians. All centers were given a 120-minute induction and provided with checklists. Patients were given detailed information and their written consent was obtained prior to the administration of mifepristone during the appointment for MAB. The centers kept lists for the purposes of documentation and for the subsequent non-responder analysis. Lists included basic parameters (age, week of gestation, number of children) and this data was also collected from patients who refused participation.

After receiving standardized information about the procedures, participants could agree to be randomized to either use LSPT for follow-up or have an ultrasound follow-up or – if they voiced a strong preference – to choose their preferred follow-up method themselves. Allocation into the randomized group was based on independent random numbers generated on the spot which resulted in a 1:1 allocation. Generation of random numbers was carried out at the same time as recruitment after receiving written consent; this ensured concealment of allocation until the number had been generated. Balance checks showed no systematic deviations from 1:1.

In the intervention group, self-testing was carried out at home 14 days after the administration of mifepristone using the low-sensitivity pregnancy test CheckTop (Nordic Pharma, cut-off: 1000 mIU/ml β-hCG in urine). The pregnancy test was administered using a set of written instructions similar to standard commercial pregnancy tests. Women in the control group underwent ultrasound examination 14 days after MAB. Participants in the LSPT group were additionally contacted by telephone six weeks after the abortion to ask about any complications occurring in the context of the MAB; a structured interview guide was used for the telephone contact.

Flow of participants

Between March and September 2024, a total of 1051 women received care for MAB in 11 facilities across Germany. 362 of these women were approached and asked to participate in the study. The main reasons not to approach women for participation were a lack of time, language barriers, and patients not yet being of legal age. 50 of the women who were approached refused to participate. Finally, a total of 312 women were included in the study. 125 participants accepted randomization (65 LSPT, 60 ultrasound) and 187 chose their preferred follow-up method (93 LSPT, 94 ultrasound). The recruitment process is shown in [Fig. 1]. The flow diagram was compiled in accordance with the recommendations of the CONSORT 2010 statement.

Fig. 1 Patient recruitment and randomization based on the CONSORT statement.

Endpoints

Primary outcome was successful detection of ongoing pregnancies. The secondary outcome was patient satisfaction, which was measured 14 days after the administration of mifepristone using two 5-point Likert scales (1 = very dissatisfied, 5 = very satisfied and 1 = felt very unsure, 5 = felt very safe).

Statistical analysis

Primary endpoint was the non-inferiority of LSPT follow-up compared to ultrasound examination with regard to the risk of missing an ongoing pregnancy up to day 14. Non-inferiority of LSPT compared to ultrasound examination was assumed if the lower limit of the one-sided 95% CI of the difference between the groups was greater than −Δ (test equivalent of two-sided 90% CI for α = 0.05). Secondary endpoints (specificity, satisfaction, and safety) were analyzed with Chi-square tests (α = 0.05; Chi-square or Fisher’s exact test for small expected frequencies) and should be interpreted as exploratory.

Binary logistic regression analysis was additionally carried out to test for the impact of the type of allocation (randomization vs. preference) as well as for possible interactions between the type of allocation and the follow-up method. The results were also analyzed separately according to whether they were randomized or preference-based.

Statistical analysis was carried out using SAS Studio.

Ethics vote and registration

The study was approved by the Ethics Committee of Bremen Medical Association (reference number 899) on February 27, 2024. At the start of the study in March 2024, the study had not been registered in a publicly available registry of studies. The study has not been registered because only limited human resources are available.

Results

Study population and group allocation

Between March 2024 and September 2024, 312 women from 11 medical practices and clinics were included in the study. 60% of the participants decided against randomization and were allocated according to their preference (s. [Table 1]). Of the patients who chose their own follow-up method based on their own strong preferences, 50.3% opted for ultrasound and 49.7% for LSPT as their preferred method.

Table 1 Demographic characteristics of the participants in the intervention and control groups. Data are presented as mean (± standard deviation, SD) or as absolute and relative frequencies (n [%]). The intervention and control groups have been additionally divided into randomized and preference-based subgroups.

Group	n	Age, mean (SD)	GW, mean (SD)	Children, mean (SD)	From a different federal state, n (%)
* Significant difference between preference groups (LSPT vs. ultrasound) with regard to place of residence outside the federal state where they received treatment (p < 0.01).
Intervention group – total	158	30.3 (6.5)	4.8 (1.1)	0.9 (1.1)	44 (30%)
Intervention group – randomized	65	31.0 (6.8)	4.6 (1.0)	0.9 (1.0)	14 (21.9%)
Intervention group – preference	93	29.7 (6.4)	4.9 (1.2)	1 (1.2)	30 (34.1%)*
Control group – total	154	29.6 (6.3)	5 (1.1)	0.9 (1.2)	27 (18%)
Control group – randomized	60	30.5 (6.9)	5.0 (1.0)	1.1 (1.2)	12 (20.7%)
Control group – preference	94	29 (5.9)	5.0 (1.1)	0.8 (1.2)	15 (16.3%)*

Sociodemographic characteristics

The demographic characteristics (age, week of gestation, parity) were largely comparable between the four study groups – i.e., randomized vs. non-randomized and intervention group vs. control group (all p > 0.05). A significant difference between groups was found with regard to place of residence: patients with a strong preference for LSPT were resident significantly more often in a different federal state from the state where the MAB was carried out (30 [34.1%] vs. 15 [16.3%], p < 0.01) (s. [Table 1]).

Follow-up outcomes and patient satisfaction

The detection rate for ongoing pregnancies was 100% in both groups. The percentage calculated for the primary non-inferiority comparison (risk difference LSPT − Ultrasound) was 0.0 percentage points; the two-sided 90% CI ranged from −1.87 to +2.40 percentage points, which means that the lower limit of the one-sided 95% confidence limit was more than −Δ (= −10 percentage points). This clearly demonstrated non-inferiority. The specificity was 93.2% for the LSPT group and 100% for the ultrasound group (s. [Table 2]) and was therefore statistically significant. Complications such as need for subsequent curettage or strong bleeding were rare in both groups and did not differ significantly. The satisfaction rate was 85.9% in the LSPT group and 98.3% in the control group, and this difference was significant (s. [Table 2]). 91% of patients who used LSPT as follow-up reported that they felt safe. 100% of patients who had a follow-up ultrasound felt safe. This difference was also significant (s. [Table 2]).

Table 2 Detection rate, specificity, satisfaction, and feeling safe according to group and allocation method. Results for detection of an ongoing pregnancy, false-positive results, satisfaction, and subjective feeling of safety are shown as absolute figures and percentages (%) of participants.

Group	N (follow-up)	Detection of ongoing pregnancy, n (sensitivity in %)	False positive, n (specificity in %)	N (satisfaction questionnaire)	Satisfaction, n (%)	Safety, n (%)
° One-sided (lower) 95% confidence limits, exact/Clopper–Pearson interval; these correspond to the lower limits of a two-sided 90% CI. Non-inferiority was tested using the risk difference LSPT − ultrasound with a two-sided 90% CI (Newcombe) against Δ = 10 percentage points. * Two-sided significance for α = 0.05 (Chi-square test; Fisher’s exact test for small expected frequencies)
Intervention group – total	110	2 (100%; CI: 16.8–100%°)	8 (92.7%)*	78	67 (85.9%)*	71 (91.0%)*
Intervention group – randomized	49	2 (100%; CI: 15.8–100%°)	4 (92.8%)*	30	26 (86.7%)*	28 (93.3%)*
Intervention group – preference	61	–	4 (93.4%)*	48	41 (85.4%)*	43 (89.6%)*
Control group – total	142	3 (100%; CI: 29.2–100%°)	0 (100%)*	119	117 (98.3%)*	119 (100%)*
Control group – randomized	57	2 (100%; CI: 15.8–100%°)	0 (100%)*	52	51 (98.1%)*	52 (100%)*
Control group – preference	85	1 (100%; CI: 2.5–100%°)	0 (100%)*	67	66 (98.5%)*	67 (100%)*

Regression analysis and subgroup analysis

Logistic regression analysis adjusted for allocation method (randomization vs. preference) showed that the follow-up method had no significant impact on the probability of being satisfied or very satisfied with follow-up (OR = 0.13; 95% CI: 0.01–1.20; p = 0.072). The allocation method (OR = 1.29; 95% CI: 0.08–21.19; p = 0.86) and the interaction term between procedure and allocation (OR = 0.70; 95% CI: 0.03–15.35; p = 0.82) were not found to be significant. A subgroup analysis found no significant differences between randomly allocated patients and patients whose allocation was preference-based, neither in terms of detection rates of ongoing pregnancies nor with regard to patient satisfaction (all p > 0.1).

Follow-up and non-responder analysis

Of the 312 patients included in the study, 252 could be contacted during the study either by telephone or in the context of follow-up (follow-up rate: 80.8%). For these patients, information was available about the clinical success, complications, and false or correct positive and negative test results. 197 patients completed and returned the questionnaire on patient satisfaction (63.1%).

A non-responder analysis was additionally carried out for the 50 women who refused to participate in the study. This group differed significantly from the group of participants in terms of their mean number of children (participants: 0.92 children; non-participants: 1.56 children; p < 0.05, t-test).

Discordant cases and safety

In the LSPT group, false-positive results were usually reported when test lines were faintly visible near the 1000 mIU/ml cut-off; this explains the lower specificity compared to the ultrasound group. There were no false-negative findings related to the detection of ongoing pregnancies. Supplement Tab. S1 (online) provides details about individual cases (faint test line and clinical course/management). In the “Further Comments” section of the questionnaire, uncertainty was repeatedly reported in the context of the appearance of faint lines on the pregnancy test; in the Discussion chapter below, we have proposed appropriate recommendations to be given to patients (e.g., carrying out a repeat pregnancy test after 48–72 h or contacting the practice/clinic early).

Discussion

The results of the study confirm those of international studies which classified LSPT as a safe follow-up method after MAB. Detection of all ongoing pregnancies indicates the reliability of the test although case numbers in our study are very low. The lower specificity of LSPT compared to ultrasound examinations can be explained by false-positive results, which usually took the form of a faint test line visible near the cut-off. This issue was mentioned several times in the “Further Comments” section of the questionnaire. The somewhat lower patient satisfaction rate in this group could be due to the lower specificity of the test and the resultant uncertainty when attempting to interpret faint positive results. A faint positive test result can make affected persons feel unsure and should be explicitly addressed as part of the initial information given to patients. Targeted advice could help reduce this uncertainty and increase patient satisfaction with LSPT. The high level of acceptance in the LSPT group, especially among patients who had travelled quite far for MAB, nevertheless underlines its potential to satisfy the requirement for needs-based local care. This is confirmed by the fact that 34.1% of the patients who preferred follow-up with LSPT had travelled to the practice/clinic from a different federal state in Germany compared to just 16.3% in the ultrasound group. The option to receive care nearer to home is therefore a relevant benefit, especially for patients who must travel further to obtain care. This points to a tension between the patient’s need for security and their desire for low-threshold, self-determined follow-up, a tension that should be considered in future models of care.

A possible selection bias may have been present due to the high percentage of participants with strong preferences about their choice of follow-up (60%) and who were therefore not randomized. However, no significant differences were found between randomized and non-randomized groups, neither with regard to the detection rates of ongoing pregnancies nor with regard to patient satisfaction. The consistency of the results across both groups is indicative of the external validity of the chosen study design.

The observed detection rate of 100% for ongoing pregnancies seems remarkably high but is plausible for several reasons. Firstly, ongoing pregnancy after medically induced abortion is a very rare event, which means that even a few correctly detected cases result in a high sensitivity. Secondly, the CheckTop test has been validated for a cut-off of 1000 mIU/ml β-hCG and the manufacturer has reported a sensitivity of 99%. When this is combined with structured patient information and a consistent medical follow-up during the study, a very high detection level is to be expected. The perfect detection rate reported for the control group is plausible as vital intrauterine pregnancies are usually clearly detectable on ultrasound. Nevertheless, the case numbers of the study are too low to permit the precise quantification of sensitivity; the confidence intervals should therefore be interpreted with caution.

Conclusion

Self-administered follow-up using a LSPT can also be a safe, accepted, and feasible alternative to ultrasound follow-up after MAB in Germany. It could contribute to improving the quality of care, especially in underserved regions, and take some of the pressure off the healthcare system. Implementation of this approach in the German healthcare system accompanied by further scientific research should be considered.

Congress contribution

An interim analysis of this study was presented in the form of a poster with the title “Effectiveness and Acceptance of Self-administered Follow-up Using a Low-sensitivity Pregnancy Test after Medical Abortion: A Partially Randomized Patient Preference Trial in Germany” at the 65th congress of the German Society for Gynecology and Obstetrics (DGGG) on October 16–19, 2024 in Berlin. This study provides a complete analysis of all included patients.

Supplementary Material

Supplement Table S1 Management of patients from the LSPT group with false-positive test results. The table presents individual cases and their data and shows their test results, complications, need for surgery (OP), whether repeat ultrasound was carried out, and whether their β-hCG value was tested during treatment.

Conflict of Interest

The study was made possible by a project-related grant of € 8000 from Nordic Pharma. The funds were used exclusively to cover the costs of materials and equipment. None of the persons involved received any remuneration. The sponsor had no influence on the study design, data collection, data analysis, or manuscript preparation at any time. There are no further financial or personal conflicts of interest beyond the above-reported funding.

Acknowledgement

The authors would like to thank all the gynecological practices and clinics involved for their support in recruiting patients and for their participation. This study was made possible by a project-related grant from Nordic Pharma (s. Conflict of Interest).

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Publication History

Received: 07 July 2025

Accepted after revision: 29 October 2025

Article published online:
08 December 2025