The efficacy of mifepristone-misoprostol regimen versus misoprostol only for medication abortion at 22+0/7 – 30+0/7 weeks gestational duration

doi:10.21203/rs.3.rs-4703601/v1

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Research Article

The efficacy of mifepristone-misoprostol regimen versus misoprostol only for medication abortion at 22+0/7 – 30+0/7 weeks gestational duration

https://doi.org/10.21203/rs.3.rs-4703601/v1

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Objective

To compare duration of medication abortion after pretreatment with mifepristone versus misoprostol-only regimens at 22 + 0/7 to 30 + 0/7 weeks gestational duration.

Methods

This retrospective cohort study included patients admitted for medication abortion from 2014 to 2022. Included patients underwent feticide due to genetic or anatomical abnormalities at gestational duration of 22 + 0/7 to 30 + 0/7 weeks. Excluded from the study were patients admitted at gestational duration of < 22 + 0/7 or > 30 + 0/7 weeks, multiple gestation, diagnosis of intrauterine fetal demise before feticide, with contraindication for vaginal delivery and who were administered a medical regimen other than the mifepristone-misoprostol or misoprostol-only protocol. Information collected included patients’ demographics, clinical outcome, additional procedural interventions, and complications. Data of patients treated with mifepristone-misoprostol versus misoprostol-only were compared.

Results

The study group included 46 patients in the mifepristone-misoprostol group and 35 in the misoprostol-only group. Median interval from first dose of misoprostol to fetal expulsion was shorter in the mifepristone-misoprostol group (10.6 vs. 15.3 h; p = 0.007) with shorter duration of hospitalization (3.5 ± 1.1 vs. 4.1 ± 1.2 days; p = 0.013). Study groups were no different in terms of complications. Patients in the mifepristone group had an earlier gestational duration (23.8 ± 1.69 vs. 25.37 ± 2.4 weeks; p = 0.002). However, multivariable Cox regression found that mifepristone-misoprostol was independently associated with shorter induction (OR 1.7, 95% CI 1.03–2.9, p = 0.03,).

Conclusion

medication abortion with mifepristone-misoprostol was associated with shorter time to fetal expulsion at 22 + 0/7 to 30 + 0/7 weeks gestational duration, compared with misoprostol-only regimen.

Mifepristone

Misoprostol

Abortion

termination of pregnancy

Pretreatment with mifepristone for medication abortion at ³22+0/7 to in <30+0/7 weeks might reduce abortion interval without additional complications.

Abortions in the second and third trimester of pregnancy are comparatively infrequent when contrasted with first trimester abortions. They arise because of fetal demise or due to genetic and anatomical anomalies, dependent on the local legality [1, 2]. Termination of pregnancy (TOP) can be achieved using medical or surgical methods based on patient preference and clinical expertise. In the second trimester (> 13 + 0/7 weeks), the common surgical method is dilatation and evacuation, requiring cervical preparation beforehand and skilled practitioners[1].

Medication abortion is the expulsion of the fetus from the uterus using pharmacological preparations. Misoprostol is a prostaglandin analogue that induces myometrial contractions to expel the fetus. Mifepristone is a competitive progesterone antagonist that primes the myometrium before the use of misoprostol [3].

The use of mifepristone-misoprostol regimen for medication abortion in the second trimester is effective and shortens the interval until fetal expulsion, compared with the use of misoprostol alone[4–10].

Despite available data, some gaps in knowledge persist. Since abortions after 20 + 0/7 weeks are less common, most data are based on patients at earlier gestational duration. In addition, studies who did include patients at this gestational duration, included a wide range of patients from 14 + 0/7 to 28 + 0/7 weeks in the same study group [4–9, 11]. Other studies that exclusively included patients at ≥ 22 + 0/7 weeks, have not shown a clear correlation between mifepristone and a shorter induction interval [11]. However, cases included in these studies were diverse, comprising intrauterine fetal demise (IUFD) and abortion after feticide in the same group, and relied on protocols that used various additional induction methods [11–17].

Abortions are physically and emotionally stressful events and may lead to short- and long-term complications. Thus, shortening the duration of the procedure can have a significant impact on a patients’ experience. A shorter abortion time can reduce the total length of hospitalization, alleviate pain, and enhance overall patient satisfaction [8, 18, 19].

Although there is good evidence to support the use of mifepristone for medication abortion in the early second trimester, the data supporting its use at > 22 + 0/7 weeks are limited. Recognizing the substantial disparities in the existing literature and acknowledging the advantage of a reliable and efficacious protocol, this study examined the outcomes of two groups of patients who underwent medication abortion at 22 + 0/7 to 30 + 0/7 weeks. One received misoprostol-only and the other mifepristone-misoprostol combined.

Patients

This retrospective cohort study included patients who were admitted to the gynecology unit at our tertiary, university-affiliated medical center, for medication abortion at 22 + 0/7 to 30 + 0/7 weeks, from January 2014 to May 2022. Patients were ages 18–45 years with indications for medication abortion based on genetic abnormalities, anatomical malformations, or patients’ medical reasons.

Excluded from the study were patients with multiple gestation, gestational duration of < 22 + 0/7 or > 30 + 0/7 weeks, who were administered other medical regimens for abortion (i.e. prostaglandin E2, osmotic dilator or balloon catheter), with contraindication for vaginal delivery, history of > 3 previous lower uterine segment or one previous classical or T-shaped cesarean delivery (CD), IUFD, spontaneous ruptured membranes or onset of labor (occurring before or after feticide), with known sensitivity to the medications used, or with hemodynamic instability (due to bleeding or other medical illness) that required urgent intervention for uterine evacuation.

Departmental Protocol

Medication abortion was performed after the approval of the institutional Pregnancy Termination Committee according to the national Termination of Pregnancy Law. All patients were hospitalized for the procedure. The gestational duration was established based on first trimester transvaginal ultrasound determined by a certified sonographer. In order to prevent unintended live births, the department’s protocol was to perform feticide prior medication abortion at 22 + 0/7 weeks or later, or when ultrasound estimated fetal weight was > 500 g. Feticide was performed using intra-amniotic injection of digoxin or direct injection of potassium chloride into the fetal heart [20]. In cases in which the first method failed, a second attempt was made using a second method.

In the misoprostol-only group, patients received 400 mcg of misoprostol buccally after the confirmation of no fetal heartbeat on sonographic examination. Subsequent buccal doses of 400 mcg misoprostol were administered at 4-hour intervals until fetal expulsion, or a maximum of 5 doses was reached. For patients with a prior history of CD, 400 mcg misoprostol buccally was administered at 6-hour intervals. In cases where fetal expulsion did not occur after the administration of 5 doses of misoprostol, an alternative regimen involving another set of 5 doses was initiated.

In 2018, guided by evidence suggesting the efficacy of mifepristone in second-trimester abortions [1, 2], our local protocol was revised. We began incorporating mifepristone as a pretreatment to the misoprostol regimen for medication abortion up to 30 + 0/7 weeks for all patients. Hence, patients admitted after the protocol changed, also received 200 mg of mifepristone orally on the day of feticide. On the subsequent day, about 24 hours later, a first dose of 800 mcg of misoprostol via the buccal route was administered. The remaining part of the protocol remained consistent across both groups (400 mcg of misoprostol buccally every 4–6 hours until fetal expulsion).

All patients administered during 2018 after the protocol changed received the mifepristone-misoprostol protocol. Successful medication abortion was defined as fetal expulsion. The abortion interval was considered from first misoprostol dose in both groups, while hospitalization period was considered from admission.

After fetus expulsion, additional procedural intervention for retained placental tissue had been taken based on visual inspection and bedside ultrasound. In cases where the placenta appeared intact and the endometrium measured less than 15 mm on ultrasound, surgical aspiration was omitted. In other cases (endometrium measured > 15 mm, when the placenta was not expelled spontaneously within 30 minutes or earlier when accompanied with major bleeding), uterine evacuation was performed by manual removal or surgical evacuation using guided ultrasound aspiration and curettage.

Outcomes

The primary outcome was the duration of abortion, measured as the interval from first misoprostol dose to fetal expulsion. Secondary outcomes were length of hospital stay, need for additional procedural intervention following fetal expulsion and complications. Early complications were defined as postpartum hemorrhage (blood volume of > 500 mL), disseminated intravascular coagulation, transfusion of blood products, and early infection (documented temperature > 38.0°C or use of antibiotics), and late complications were defined as readmission or late infection (defined as infection after discharged within first 30 days).

Data

Data were abstracted manually from electronic medical records of all patients admitted for medication abortion at ≥ 20 weeks from January 2014 to May 2022 and included patients’ demographics, obstetric and gynecologic history, and information regarding the relevant pregnancy. Parameters related to the abortion procedure, medical regimen, surgical intervention, and complications were also recorded. Length of hospital stay was calculated from admission.

For study purposes, pre-abortion data, medical abortion duration and patients’ outcomes were compared between patients who used the mifepristone-misoprostol protocol to the misoprostol-only group.

Ethical considerations

This study was performed in accordance with the principles of the Declaration of Helsinki. All methods were carried out in accordance with relevant guidelines and regulations. Study protocol was approved by Meir Medical Center Ethics Committee #MMC238-22. Due to the retrospective nature of the study, the Ethics committee waived need for informed consent.

Statistical analysis

Categorical variables were summarized as numbers and percents. The distribution of continuous variables was evaluated using the Kolmogorov-Smirnov test. For reader ease, all continuous variables were reported as mean and standard deviation, unless mentioned otherwise. The categorical variables were compared between the two groups using chi-square test or Fisher’s exact test. Continuous and ordinal variables were compared between groups using independent samples t-test or Mann-Whitney test.

Kaplan-Meier curve was used to describe fetal expulsion time from first misoprostol and log-rank test was used to compare between the two groups. Univariate Cox regression was used to study the association between each variable and the time to fetal expulsion. Multivariable Cox regression was used to study the association between mifepristone and the time until fetal expulsion after the first dose of misoprostol. Previous abortions, gestational duration, previous vaginal delivery, and epidural analgesia were considered as possible confounders. Multivariable logistic regression was used to study the association between the treatment with mifepristone and the need for procedural interventions, while controlling for potential confounders. Patient age, gestational duration, previous CD, and previous dilation and curettage were considered possible confounders, and a backward method was applied using the Wald test as criteria for variable removal (P 0–1). All statistical tests were two sided and p < 0.05 was considered statistically significant. NCSS 2022 software was used for all statistical analyses (NCSS Statistical Software, LLC. Kaysville, UT, USA).

During the study period, 248 patients were admitted to our unit for medication abortion at > 20 weeks. After excluding patients with multiple gestation, IUFD, treatment with other regimens or protocols, and spontaneous rupture of membranes or labor, 81 patients met the inclusion criteria: 46 (56%) in the mifepristone-misoprostol group and 35 (44%) in the misoprostol-only group (Fig. 1).

Table 1 presents the demographic and clinical characteristics of the study groups. In the mifepristone-misoprostol group, mean gestational duration was earlier than in the misoprostol-only group (23.8 ± 1.69 vs. 25.37 ± 2.4 weeks, respectively; p = 0.002). There were no significant differences in other characteristics between groups.

All patients delivered vaginally except one in the misoprostol-only group who required cesarean hysterotomy (due to patient request after failed fetal expulsion following 5 doses of misoprostol). In the mifepristone group, the mean time from mifepristone administration to the first dose of misoprostol was 20.8 ± 4.1 hours. The interval until fetal expulsion was shorter in the mifepristone group [median (range): 10.6 (1.7–36.4) hours vs. 15.3 (4.7–53.9), p = 0.007; Fig. 2]. This finding was significant after controlling for previous abortions, gestational duration, previous vaginal delivery, and epidural analgesia, using multivariable Cox regression [odds ratio (OR) 1.7, 95% confidence interval (CI) 1.03–2.9, p = 0.03].

Table 2 presents the outcomes of the study groups. Patients in the mifepristone-misoprostol group had shorter hospital stays (3.5 ± 1.1 vs. 4.1 ± 1.2 days, respectively; p = 0.013). This group had higher rate of procedural intervention for retained placental tissue (60.9% vs. 34.3%, p = 0.018). However, a multivariable logistic regression revealed that mifepristone was not independently associated with increased need for procedural intervention. Longer gestational duration was associated with reduced procedural intervention, while previous dilation and curettage was associated with increased need for procedural intervention (Table 3). There were no other significant differences in terms of early or late complications.

The results of this this retrospective cohort study indicate that pretreatment with mifepristone before administering misoprostol for medication abortion at gestational duration of 22 + 0/7 to 30 + 0/7 weeks was associated with shorter abortion duration. The median time for fetal expulsion was 10.6 hours, significantly shorter than 15.3 hours in the misoprostol-only group. Patients in the mifepristone group required more procedural intervention after fetal expulsion. No notable increase in other complications was associated with the use of mifepristone.

The current study successfully demonstrates the potential effectiveness of mifepristone on decreasing abortion duration in this specific population of patients. We included cases in which medication abortion was initiated after feticide for uniformity and because medication abortion after fetal demise might be shorter, regardless of the regimen used [2, 9, 21–23]. Included in the study patients with gestational duration of ≥22 + 0/7 weeks because the little available data at these weeks and because after this gestational duration feticide was routinely performed at our department, in order to prevent unintended live births. Medication abortion using misoprostol was limited to gestational duration of < 30 + 0/7 weeks in accordance with the local protocol, patients with later gestational duration were managed with different regimens. [2, 23].

Although previous studies established the efficacy of mifepristone for shortening medication abortion in the second trimester, the available data at > 22 + 0/7 weeks are limited [2, 9, 23]. Previous studies investigated mifepristone efficacy in second-trimester abortions, consistently indicating shorter labor duration [5, 9, 24]. However, these studies included pregnancies with earlier gestational duration, beginning from 12 weeks. A study that included pregnancies at 20–27 weeks, found a shorter duration with the addition of mifepristone. However, it included pregnancies with fetal demise along with TOP in the same group [12]. In contrast, another study that included only patients who underwent TOP at ≥ 24 + 0/7 weeks found no difference in abortion time with the use of mifepristone [11]. However, the protocol used in that study included the insertion of osmotic dilators in all patients before the first dose of misoprostol.

The present study showed that mifepristone was also associated with a minimal decrease in overall hospital stay, as seen in previous studies. Shorter hospital stay is more cost-effective and may improve the abortion experience [8]. It is worth mentioning that during the study period, patients in the mifepristone group were hospitalized at the day of the feticide and mifepristone administration. Previous studies have shown the safety of self-administered mifepristone without requiring an observation period [25, 26]. Thus, we believe that the hospital stay could be shortened even more if patients were hospitalized only when misoprostol was administered, about 24 hours later.

Patients in the mifepristone group had a higher procedural intervention after fetal expulsion (60.9% vs. 34.3%, respectively; p = 0.018). Although mifepristone was not found to be independently associated with retained placental tissue (Table 3), as shown in previous studies, this group might have experienced a higher intervention rate due to the difference in the mean gestational duration [3, 6, 11, 12]. Another possible explanation for this difference is a lower threshold for intervention in recent years, when the mifepristone protocol was used. However, and despite the retrospective nature of this study, to the best of our knowledge the main change in the treatment protocol during the study period was the addition of mifepristone, as described earlier.

The current study has several notable strengths. The cohort was exclusively composed of cases where medication abortion carried after feticide at a gestational duration of ≥ 22 + 0/7 and < 30 + 0/7weeks, while most other studies lack the data past 22 + 0/7 weeks. Second, both study groups underwent treatment within the confines of the same tertiary, university-affiliated medical center, following similar protocols, with the main difference being the addition of mifepristone as pretreatment.

The study had certain limitations. The relatively modest sample size, coupled with its retrospective nature, bears the potential of introducing undetected biases and constraining the applicability of the findings on a broader scale. Notably, there was a disparity in the mean gestational duration between the groups. This difference is mostly notable in the later gestational duration (25 to 27 weeks and in the > 28 weeks), a subgroup of patients with especially limited data in the current literature. A plausible explanation for this difference might be the earlier diagnosis of genetic abnormalities prompting TOP in recent years, when the mifepristone regimen was used, as result of the increased use of chromosomal microarray analysis for prenatal diagnosis in our local population. However, a univariate Cox regression analysis revealed no discernible correlation between gestational duration and the duration to fetal expulsion. Moreover, a multivariate Cox regression indicated that mifepristone was independently linked to a shorter interval until fetal expulsion. The difference in the first dose of misoprostol between the groups (800 mcg in the mifepristone group, compared with 400 mcg in the misoprostol-only group) is another limitation. However, there was no difference in the cumulative dosage of misoprostol administered between the groups (1608 ± 523 vs. 1611 ± 766 mcg, p = 0.83).

This study has successfully established an association between pretreatment with mifepristone and shorter interval to fetal expulsion among patients who underwent medication abortion at gestational duration of 22 + 0/7 to 30 + 0/7 weeks. This contribution is particularly significant considering the paucity of data within this specific subject area and could potentially provide valuable insights to both patients and clinicians when selecting the optimal treatment regimen. However, a RCT is needed to comprehensively explore the impact of mifepristone within this specific gestational duration.

Author contributions

O Touval: project development, data collection, data analysis and manuscript writing

A Ellert: data collection and data analysis.

Y Daykan: data analysis and manuscript editing.

R Schonman: data analysis and manuscript editing.

Z Klein: data analysis and manuscript editing.

Y Yagur: project supervisor, data analysis and manuscript editing.

Conflict of interest statement

The authors have no relevant financial or non-financial interests to disclose.

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Table 1. Demographic and clinical characteristics of the study groups

*Variable^a*	*Mifepristone + Misoprostol* n=46	*Misoprostol-only* n=35	*p-value*^a
Age, years	33.5±5.83	33±6.08	0.708
Smoking	4 (8.7%)	1 (2.86%)	0.38
Gravidity	3.1±1.67	2.6±1.49	0.202
Parity	1.41±1.46	1.02±1.07	0.098
Nulliparous	11 (23.9%)	13 (37.1%)	0.196
Previous vaginal delivery	28 (60.87%)	20 (57.1%)	0.735
Previous cesarean delivery	9 (19.6%)	4 (11.4%)	0.37
Previous abortion	23 (50%)	10 (28.6%)	0.052
Previous dilation and curettage	12 (26.1%)	4 (11.43%)	0.16
Gestational duration, weeks (mean)	23.8±1.69	25.37±2.4	0.002
22-24	34 (73.9%)	13 (37.7%)
25-27	10 (21.7%)	17 (48.5%)
28-30	2 (4.3%)	5 (14.3%)
Hemoglobin on admission, g/dL	11.6±1.07	11.05±1.27	0.063
Total misoprostol dose, mcg	1608±523	1611±766	0.83
Epidural analgesia	41 (89.13%)	30 (85.71%)	0.74

^aData are shown as number (%) or mean ± standard deviation, as appropriate.

^bP-values derived from t-test, Mann-Whitney, chi-square, and Fisher’s exact tests

Table 2. Outcome characteristics of study groups

*Variable^a*	*Mifepristone-misoprostol* n=46	*Misoprostol-only* n=35	p-value^f
Procedural intervention^b	28 (60.9%)	12 (34.3%)	0.018
Length of hospital stay (days)	3.52±1.1	4.08±1.22	0.013
Hemoglobin after fetal expulsion (g/dL)	10.89±1.61	10.21±1.51	0.13
Total early complications^c	9 (19.6%)	4 (11.43%)	0.37
Postpartum hemorrhage	2 (4.35%)	3 (8.57%)	0.65
Disseminated intravascular coagulation	1 (2.17%)	0	>0.99
Transfusion of blood products	2 (4.35%)	0	0.5
Infection^d	8 (17.39%)	1 (2.86%)	0.07
Late complications^e	3 (6.52%)	0	0.25
Readmission	2 (4.35%)	0	0.5
Late infection	3 (6.52%)	0	0.25

^aData are shown as number (%) or mean ± standard deviation, as appropriate.

^bSurgical or manual removal of placental tissue after fetal expulsion

^cTotal complications include PPH, DIC, blood product transfusion, and infection.

^dDocumented temperature of >38.0°C or use of antibiotics.

^eLate complication includes readmission within 30 days after hospital discharge and late infection (documented temperature of >38.0°C or use of antibiotics after hospital discharge)

^fp-values derived from t-test, Mann-Whitney, chi-square, and Fisher’s exact tests

Table 3. Factors associated with increased procedural interventions following fetal expulsion^a

*Variable*	*Odds Ratio*	*95% CI*	p-value
Gestational duration	0.73	0.56-0.94	0.01
Previous cesarean delivery	3.29	0.81-13.3	0.09
Mifepristone	1.56	0.54-4.46	0.4
Previous dilation and curettage	4.84	1.17-20.05	0.03

^aprocedural interventions: manual removal of placenta, uterine revision, and aspiration and curettage.

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The efficacy of mifepristone-misoprostol regimen versus misoprostol only for medication abortion at 22+0/7 – 30+0/7 weeks gestational duration

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