Is oral misoprostol more effective than vaginal dinoprostone for cervical ripening in women with preeclampsia or gestational hypertension: a retrospective cohort study

doi:10.21203/rs.3.rs-3142437/v1

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Is oral misoprostol more effective than vaginal dinoprostone for cervical ripening in women with preeclampsia or gestational hypertension: a retrospective cohort study

https://doi.org/10.21203/rs.3.rs-3142437/v1

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OBJECTIVE: To compare the effects of oral misoprostol and vaginal dinoprostone on cervical ripening and labor induction among patients with preeclampsia or gestational hypertension.

METHODS: A total of 123 women with preeclampsia or gestational hypertension, who had indications for pregnancy termination and no contraindications for vaginal delivery at 37 weeks of gestation or beyond, with Bishop scores below 6, were included in this trial conducted at Hebei General Hospital in Shijiazhuang, Hebei, China, between October 2022 and May 2023. Participants were randomly assigned to receive either oral misoprostol or vaginal dinoprostone. In the oral misoprostol group (n=60), a dose of 25 to 50µg was administered every 2 or 4 hours. In the vaginal dinoprostone group (n=63), the 10mg dinoprostone vaginal insert was administered as per the drug protocol. The efficacy and safety of oral misoprostol were compared to those of vaginal dinoprostone for labor induction in women with preeclampsia or gestational hypertension.

RESULTS: The duration of induction to cervical ripening was significantly longer in the oral misoprostol group compared to the vaginal dinoprostone group (32.77 hours vs 16.09 hours, p=0.007). Similarly, the delivery time was longer in the oral misoprostol group compared to the vaginal dinoprostone group (39.15 hours vs 11.57 hours, p=0.019). The time from cervical ripening to delivery was also longer in the oral misoprostol group compared to the vaginal dinoprostone group (10.85 hours vs 4.5 hours, p=0.004).

Compared to vaginal dinoprostone, the use of oral misoprostol resulted in a higher need for additional induction methods such as oxytocin, mechanical devices, or amniotomy (43.33% vs 4.76%, p＜0.001). However, there was a lower incidence of hyperstimulation with oral misoprostol compared to vaginal dinoprostone (5% vs 28.57%, p=0.001, RR 0.26, 95% CI 0.08 to 0.74). There was no significant difference in the rate of cesarean delivery between the two groups. Nevertheless, it is worth noting that women who received oral misoprostol had a significantly lower likelihood of undergoing cesarean delivery due to non-reassuring fetal heart rate (20% vs 66.67%, p=0.04, RR 0.25, 95% CI 0.07 to 0.98) compared to those in the vaginal dinoprostone group. No cases of severe neonatal or maternal morbidity were reported, and there were no significant differences in other clinically relevant outcomes.

CONCLUSIONS: In terms of induction and delivery time, oral misoprostol appears to be less effective than vaginal dinoprostone. While it results in a lower frequency of tachysystole and non-reassuring fetal heart rate (FHR) changes, the rates of cesarean delivery and maternal and fetal complications are similar between the two groups. Additionally, the oral misoprostol group requires additional methods to achieve vaginal delivery. Therefore, oral misoprostol does not demonstrate superiority in achieving vaginal delivery for patients with preeclampsia or gestational hypertension.

Gestational hypertension(GH) and preeclampsia(PE) are prevalent disorders during pregnancy, often associated with maternal and perinatal complications. While various antihypertensive treatments exist, delivery remains the only effective means to prevent serious complications [1]. Therefore, selecting an appropriate method for labor induction is vital in reducing maternal and fetal complications while minimizing risks.

Misoprostol, a synthetic analog of prostaglandin E1, was initially used for the prevention of peptic ulcers. It has since been found to be effective for cervical ripening and labor induction; however, it can also increase the risk of uterine hyperstimulation [2]. Therefore, it is important to strike a balance between uterine contractions, delivery time, and the risk of excessive uterine stimulation. Oral misoprostol may offer several advantages over other methods of labor induction, as it is easier to administer, more acceptable to women, and has a lower risk of hyperstimulation compared to vaginal administration [3].

The objective of this study is to evaluate and compare the effectiveness of oral misoprostol and vaginal dinoprostone in cervical ripening. Furthermore, it aims to determine whether oral misoprostol is superior in achieving vaginal delivery for patients with PE or GH.

2.1 Participants sources

The retrospective study was conducted at Hebei General Hospital in Shijiazhuang, Hebei, China, from November 2022 to March 2023. The study included 123 patients with PE or GH who had indications for pregnancy termination. The selection of the induction method was determined by a deputy chief physician or higher, in consultation with the patient. The trial enrolled 60 patients in the oral misoprostol group and 63 patients in the vaginal dinoprostone group.

This project belongs to a retrospective study, and the clinical intervention measures are not affected by experimental factors, and there is no possibility of serious complications or adverse consequences brought about by the experiment itself on the experimenter. All participants were informed that each provided an informed consent.

2.2 Inclusion criteria

The inclusion criteria for the study were as follows: patients with PE or GH who required pregnancy termination at 37 weeks of gestation or beyond, with a predetermined plan for preinduction cervical ripening. Additional criteria included singleton pregnancies, an unfavorable cervix with a Bishop score below 6, intact membranes, normal fetal heart rate (FHR), and no contraindications for vaginal delivery. Exclusion criteria encompassed cases of fetal death, fetal abnormalities, prior uterine scar, non-reassuring FHR, premature rupture of membranes, severe preeclampsia or eclampsia, chorioamnionitis, premature delivery, or placenta previa.

2.3 Methods of administration

In the misoprostol group, a 200 microgram misoprostol tablet (Renfu Pharmaceutical Co., Ltd, Hubei, China) is dissolved in 200mL of tap water. Accurate volumes are measured for administration, and an initial dose of 25mg is given every 2 hours. Subsequently, the dose is adjusted to 25mg every 2 hours or 50mg every 4 hours until effective uterine contractions occur (defined as three or more painful contractions in 10 minutes) or until the cervix reaches a favorable Bishop score of 6 or above. The maximum daily dose does not exceed 200mg. If effective uterine contractions do not occur, administration is halted after 22:00, and the cervix is reassessed the following day. If vaginal delivery is not achieved within 48 hours, additional induction methods such as oxytocin, mechanical devices, amniotomy, or their combination may be required.

In the vaginal dinoprostone group, a 10mg dinoprostone vaginal insert (Ferring Therapeutics Ltd, Scotland, UK) is administered according to the drug protocol. The dinoprostone insert is removed when effective uterine contractions occur, cervical ripening is achieved, membrane rupture occurs, uterine tachysystole is observed, or non-reassuring FHR changes are detected. In cases of uterine tachysystole, intravenous administration of 5g of magnesium sulfate is performed, with a slow continuous administration of 1-2g/h if stimulation suppression is difficult. The delivery process is managed by the supervising doctor.

2.4 Data collection

The primary outcomes observed in this study were the rate of vaginal delivery within 24 and 48 hours, the duration of cervical ripening, the duration from cervical ripening to delivery, the requirement for additional induction methods, and maternal and fetal adverse consequences. Maternal adverse consequences encompassed uterine tachysystole with or without FHR changes, the frequency of cesarean delivery, postpartum hemorrhage, suspected infection, operative vaginal delivery, and lower pain scores. Fetal adverse consequences included the frequency of cesarean delivery due to non-reassuring FHR, Apgar scores below 7, admission to the neonatal intensive care unit (NICU), and cesarean delivery.

2.5 Statistical analysis

Statistical analyses were performed using SPSS software (Statistical Package for the Social Sciences, version 24.0, SPSS Inc., Chicago, IL, USA). The independent-samples t-test was utilized to assess the equality of means, while the Chi-square test or Fisher's exact test was employed for the analysis of categorical variables in 2x2 table data. A p-value less than 0.05 was considered statistically significant.

The baseline characteristics of the two groups, including age, gestational age, Bishop score, parity, and body mass index (BMI), did not exhibit any significant differences (p > 0.05, Table 1). The average indicated gestational age in the oral misoprostol group was 38.97 weeks, while it was 39.24 weeks in the vaginal dinoprostone group. The proportion of nulliparous participants was similar to that of multiparous participants.

The cervical ripening time with oral misoprostol was 32.77 ± 20.37 hours, whereas it was 16.09 ± 16.42 hours with vaginal dinoprostone. The induction to delivery time was significantly longer in the misoprostol group compared to the dinoprostone group (39.15 ± 28.21 hours vs. 11.57 ± 8.56 hours, p = 0.019). Only 12% of women in the oral misoprostol group achieved vaginal delivery within 24 hours, in contrast to 84.44% in the dinoprostone group (p < 0.001). In the oral misoprostol group, 40% of women delivered within 24 hours, and 48% delivered within 48 hours (Table 2).

If contractions became inadequate or if the woman had an unfavorable cervix, additional induction methods such as oxytocin or a combination of oxytocin and amniotomy were initiated. It appears that the oral misoprostol group experienced a higher failure rate in achieving vaginal delivery through a single method compared to the dinoprostone group (43.33% versus 4.76%, p < 0.001). In fact, a majority of the misoprostol group (69.23%) required two induction methods. However, there were no statistically significant differences observed in the labor process between the two groups (Table 2).

Regarding maternal and neonatal adverse events, a significant difference was observed in the occurrence of uterine hyperstimulation, with a lower incidence in the oral misoprostol group compared to the dinoprostone group (5% vs. 28.57%, p = 0.001, RR 0.26, CI 0.08–0.74).There were no significant differences between the two groups in terms of neonatal first-minute Apgar scores and admission to the NICU. Similarly, although the rates of forceps use, episiotomy, and postpartum hemorrhage were higher in the vaginal dinoprostone group compared to the misoprostol group, the differences were not statistically significant (p = 0.44, p = 0.53, p = 0.21). The need for cesarean delivery did not significantly differ between the oral misoprostol and vaginal dinoprostone groups (RR 0.68, 95% CI 0.40–1.57). Among the causes of cesarean delivery, the proportion of cesarean deliveries due to non-reassuring fetal heart rate was higher in the dinoprostone group than in the oral misoprostol group (66.67% vs. 20%, p = 0.04, RR 0.25, CI 0.07–0.98). Conversely, the proportion of cesarean deliveries due to suspected chorioamnionitis was higher in the oral misoprostol group compared to the dinoprostone group (40% vs. 5.56%, RR 3.01, CI 1.36–6.93). No significant differences were observed in the occurrence of cesarean deliveries due to personal requirements between the two groups (As shown in Table3).

Table 1

Baseline Characteristics of the Study Population*
Variable	OM group(n = 60)	VD group (n = 63)	P-value
Age(years)	29.65 ± 3.57	30.21 ± 3.54	0.50
Gestatiom at induction (Weeks)	38.97 ± 1.42	39.24 ± 0.89	0.38
Nulliparous	42	42	0.69
Multiparous	18	21	0.69
Bishop score	3.80 ± 0.89	3.96 ± 0.97	0.31
BMI (kg/m2)	21.73 ± 3.45	23.73 ± 4.18	0.06

The data are presented as number (%) or mean ± SD. Statistically signifificant P < 0.05.

Table 2

Labor outcomes
Variable	OM group(n = 60)	VD group (n = 63)	P-value
Cervical ripening time(h)	32.77 ± 20.37	16.09 ± 16.42	0.007^*
Delivery time	39.15 ± 28.21	11.57 ± 8.56	0.019^*
Cervical ripening time to delivery ＜24 h 24-48h 48h above	10.85 ± 4.42 6(12) 20(40) 24(48)	4.50 ± 2.42 38(84.44) 6(13.33) 1(2.22)	0.004^* 0.000^* 0.004^* 0.000^*
keenly feel	20(33.33)	31 (49.21)	0.07
More than 1 methods needed	26(43.33)	3(4.76)	0.000^*
One method (Oxytocin) Two methods (oxytocin and amniotomy or devices) Three methods (oxytocin, amniotomy and devices)	6(23.08) 18(69.23) 2(7.69)	2(66.67) 1(33.33) 0(0)
Partus precipitatus	3(6)	3(6.67)	1.0
^*P < 0.05

Table 3

Outcomes of Maternal and Neonatal adverse events
Variable	OM group(n = 60)	VD group (n = 63)	P-value	RR(95%CI)
Maternal adverse events
Forceps	2(4)	5(11.11)	0.44	0.42(0.16–1.72)
Episiotom	8(16)	11(24.44)	0.53	0.76(0.43–1.34)
Cesarean delivery	10(16.67)	18(28.57)	0.11	0.68(0.40–1.57)
Causes of FHR changes	2(20)	12(66.67)	0.04^*	0.25(0.07–0.98)^a
Suspected chorioamnionitis	4(40)	1(5.56)	0.01^*	3.01(1.36–6.93)
Personal requirements	4(40)	5(27.78)	0.68	1.73(0.34–8.87)
Postpartum hemorrhage	1(1.67)	5(7.94)	0.21	0.33(0.06-2.0)
Hyperstimulation	3(5)	18(28.57)	0.001^*	0.26(0.08–0.74)^b
Neonatal adverse events
Admission to NICU	2(3.33)	4(6.35)	0.674	0.68(0.22–2.15)
Apgar score ≤ 7 at 1 min	0	1	1.0	1.95(1.64–2.32)
^*P < 0.05
a:Causes of FHR changes,OM vs VD:OM causes fewer changes in FHR;

b:Hyperstimulation,OM vs VD:OM causes fewer hyperstimulation.

Gestational hypertension and preeclampsia are complex complications of pregnancy that require careful management. These conditions arise due to abnormalities in the placenta and can only be resolved through delivery [4]. When mild hypertension or preeclampsia occurs close to term, the associated risks to both the mother and baby are minimal, making vaginal delivery a viable option [4–5]. Consequently, the induction of labor and cervical ripening become crucial steps in the management process. Prostaglandin drugs and mechanical methods are commonly employed for cervical ripening and labor induction, each offering their own benefits and associated risks [6–7].

Dinoprostone, a form of prostaglandin E2, is known for its effectiveness in labor induction and improvement of the cervical score [8]. However, its use may be associated with unwanted side effects such as uterine tachysystole, fetal distress, and an increased risk of cesarean delivery [9–10]. Misoprostol, a synthetic analogue of prostaglandin E1, has emerged as a safe, affordable, and easily administered alternative for cervical ripening and labor induction. Nonetheless, when administered sublingually or vaginally, misoprostol still carries a risk of uterine tachysystole [11]. Studies have shown that women with hypertensive disorders tend to experience shorter labors compared to normotensive women undergoing induction, which may be attributed to factors like birthweight and gestational age [12–13]. In light of these considerations, the use of vaginal misoprostol or vaginal dinoprostone for cervical ripening and labor induction in patients with preeclampsia or gestational hypertension may not be entirely safe and could potentially lead to adverse pregnancy outcomes. Consequently, researchers have been investigating the use of low-dose oral misoprostol, which has demonstrated efficacy in achieving delivery while minimizing hyperstimulation [9, 14–15]. The 2023 SOGC Guidelines recommend the use of oral misoprostol as the preferred method for cervical maturation and induction of labor [3]. Oral misoprostol, when dissolved in plain water, rapidly dissolves and remains stable for 24 hours, allowing for accurate and adjustable oral dosing [16]. The objective of our study was to explore whether oral misoprostol is superior to vaginal dinoprostone in patients with gestational hypertension and an unripe cervix.

In our study, we observed that the induction to cervical ripening time and delivery time were significantly longer in the oral misoprostol group compared to the dinoprostone group (p = 0.007, p = 0.019). Additionally, the percentage of women who delivered within 24 hours was lower in the oral misoprostol group (12% vs 84.4%, p＜0.001). In contrast, almost all patients in the dinoprostone group delivered within 24 hours, whereas the oral misoprostol group had a lower rate of timely delivery. Within 48 hours, 40% of patients in the oral misoprostol group delivered, while 48% required more than 48 hours for delivery. Our findings align with a study conducted by Kerr, Robbie S et al., which demonstrated similar results. They reported that 57–64% of women were able to deliver within 24 hours with oral misoprostol, leading to fewer cesarean deliveries for fetal distress and lower rates of hyperstimulation [17]. Beyer J et al. also suggested that oral misoprostol had higher efficacy compared to vaginal misoprostol and vaginal dinoprostone, with 87.5% of women delivering within 24 hours [18]. However, the study by Arif R et al. yielded different results from our study. They found that vaginal misoprostol shortened the time between induction and delivery compared to the dinoprostone group, with more women in the misoprostol group delivering within 12 and 24 hours [19]. Based on our study, it appears that oral misoprostol requires a longer duration for cervical ripening and delivery compared to vaginal misoprostol and dinoprostone. The effectiveness of oral misoprostol in achieving timely delivery may be lower than that of vaginal dinoprostone. Further research is necessary to determine the optimal dosage and interval between oral doses.

Labor induction with vaginal dinoprostone has been independently associated with a higher rate of cesarean sections compared to oral misoprostol (adjusted odds ratio [aOR] = 2.44; 95% confidence interval [CI] 1.35–4.40; p = 0.003) [20]. However, in our study, we did not find a statistically significant difference in the need for cesarean delivery between the oral misoprostol and vaginal dinoprostone groups (relative risk [RR] = 0.68; 95% CI 0.40–1.57). Although there was a small difference in cesarean delivery rates, oral misoprostol still demonstrated effectiveness as an intervention.

Among the causes of cesarean delivery, a greater proportion of cesareans in the dinoprostone group were performed due to non-reassuring fetal heart rate. Additionally, in patients with premature rupture of membranes after 35 weeks, there were more cesarean sections for abnormal fetal heart rate in the vaginal misoprostol group [21]. This suggests that oral misoprostol may lead to a lower incidence of changes in fetal heart rate. Another study by Wang X et al. reported that oral misoprostol resulted in a lower incidence of cesarean delivery, lower frequency of tachysystole with changes in fetal heart rate, and non-reassuring fetal heart rate in nulliparous women at term pregnancy (3.6% vs 8.6%, p = 0.007) [22]. Consistent with these findings, our study demonstrated that the rate of tachysystole was lower with oral misoprostol compared to dinoprostone (5% vs 28.57%, p = 0.001, RR 0.26 CI 0.08–0.74). Furthermore, there was no significant difference between the two groups regarding neonatal outcomes.

Taken together, it is evident that oral misoprostol is a safe, inexpensive, and easily administered option for labor induction. A meta-analysis including 33 randomized controlled trials with 5,162 patients concluded that the oral misoprostol group had a lower risk of maternal and fetal complications compared to the vaginal misoprostol group, including neonatal death, tachysystole, uterine hyperstimulation, the need for oxytocin, and higher rates of cesarean fever [23]. However, it is worth noting that in the oral misoprostol group, there appears to be a higher rate of failure to achieve vaginal delivery with a single method (43.33% vs 4.76%, p＜0.001), and a significant proportion (69.23%) required two induction methods.

In conclusion, compared to vaginal dinoprostone, oral misoprostol requires a longer duration for induction and delivery. The majority of patients in the oral misoprostol group could not achieve delivery within 24 hours, with only 52% delivering within 48 hours, while almost all patients in the vaginal dinoprostone group delivered within these time frames. The rates of cesarean delivery and maternal and fetal complications were similar between the two groups. However, oral misoprostol was associated with a lower frequency of tachysystole and non-reassuring fetal heart rate changes. It also showed a higher likelihood of failure to achieve vaginal delivery through a single method, necessitating the use of additional methods.

Considering the small difference in cesarean delivery rates and the similarity in neonatal and maternal morbidity rates, the choice of cervical ripening and induction method should be based on the gestational age of the patient and a careful assessment of the clinical risk-to-benefit ratio. Informed consent should be obtained from the patient regarding the chosen method.

One limitation of this study is its retrospective design, which may introduce inherent biases and limitations in data collection and analysis. Additionally, the variability in methods used to promote cervical maturation after oral misoprostol could have influenced the delivery outcomes, potentially impacting the results. Another factor to consider is the potential impact of interrupting oral misoprostol administration at night, which could potentially reduce the success rate of induction. Given the relatively fewer complications associated with oral misoprostol compared to other methods, further studies should be conducted in the future to explore its efficacy and safety in a more controlled and standardized manner. This would help provide more robust evidence regarding the effect of oral misoprostol in cervical ripening and labor induction.

Gestational hypertension

preeclampsia

FHR

fetal heart rate

NICU

neonatal intensive care unit

Oral Misoprostol

Vaginal Dinoprostone

BMI

body mass index

standard deviation

Relative risk

Confidence interval.

Acknowledgements

The authors thank all the doctors, nurses, and midwifes in the Hebei General Hospital of Obstetrics for their help in collecting data.

Authors' contributions

Zhang C: protocol development, data collection, management and writing of manuscript;Li SS: data collection, management; Jiang JJ: data analysis and revision of the manuscript; Jia L: data collection; Tian ML: data collection and draft writing;Jin Y:data collection and revision of the manuscript.

Funding

No funding was received.

Availability of data and materials

The data used or analyzed during the current study are included within the article. The datasets are not publicly available due to the hospital policy and personal privacy. However, the datasets are available from the corresponding author on reasonable request.

Ethics approval and consent to participate

All methods were carried out in accordance with relevant guidelines and regulations. All experimental protocols were approved by Hebei General Hospital Ethics Committee（Protocol number: K-2021-1041）.The informed consent was obtained from all the participants.

Consent for publication

Not applicable.

Competing interests

The authors have no conflicts of interest.

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No competing interests reported.

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Is oral misoprostol more effective than vaginal dinoprostone for cervical ripening in women with preeclampsia or gestational hypertension: a retrospective cohort study

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Abstract

1 Introduction

2 Materials and Methods

2.1 Participants sources

2.2 Inclusion criteria

2.3 Methods of administration

2.4 Data collection

2.5 Statistical analysis

3 Results

4 Discuss

Abbreviations

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References

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