Randomized Comparison of Isosorbide Mononitrate and PGE2 Gel for Cervical Ripening at Term including High Risk Pregnancy

Agarwal, Krishna; Batra, Achla; Batra, Aruna; Aggarwal, Abha

doi:10.1155/2014/147274

Cited by 9 publications

(17 citation statements)

References 17 publications

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“…In a study conducted by Agarwal et al, 3 the mean age group was 23.4 years in the IMN group and 23.57 years in the PGE2 group, which closely correlates with our study. Also, the findings in Duhan et al, 4 Dave et al, 5 Yazdizadeh et al, 6 and Krishnamurthy et al 7 were comparable with our study.…”

Section: Discussionsupporting

confidence: 92%

See 1 more Smart Citation

Effectiveness of Isosorbide Mononitrate vs Prostaglandin E2 Gel for Cervical Ripening: A Study

Somalwar¹,

Tathe²,

Dixi³

2019

Journal of South Asian Federation of Obstetrics and Gynaecology

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Background: Till date, search is going on for an ideal agent that can lead to cervical ripening and induction of labor and that is safe for mother and fetus. Isosorbide mononitrate (IMN) is an agent that is also used for preinduction cervical ripening but few studies are done with this drug and hence this study was carried out. Aims and objectives: To study efficacy of IMN and PGE2 gel for preinduction cervical ripening and to study side effects of both drugs. Materials and methods: It was a randomized controlled trial. Participants were selected according to the selection criteria. Group I included 100 participants in whom tab IMN was used. Group II included 100 participants in whom PGE2 gel was used. Outcome measures assessed were age, parity, gestational age, indication for induction of labor, assessment of modified Bishop's score (MBS) at 0 and 24 hours, change in MBS, and drug-related side effects. Statistical analysis was done. Results: Mean age, parity, and mean gestational age were comparable in both groups. Postdatism and preeclampsia were indications for induction in both groups. Modified Bishop's score at 0 hour was comparable in both groups. Change in the MBS at 24 hours was 2.91 ± 1.34 in group I and 4.52 ± 2.22 in group II. Drug-related side effects were more in group I than in group II. Conclusion: PGE2 gel was more effective for cervical ripening as compared to IMN. Isosorbide mononitrate leads to more side effects.

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Section: Discussionsupporting

confidence: 92%

“…Sample size was calculated by power analysis with the help of mean and standard deviation based on the previous study 3 with power of 80% (α = 0.05 and β = 0.2). The total sample size of the present study was 200.…”

Section: Materials a N D Methodsmentioning

confidence: 99%

Effectiveness of Isosorbide Mononitrate vs Prostaglandin E2 Gel for Cervical Ripening: A Study

Somalwar¹,

Tathe²,

Dixi³

2019

Journal of South Asian Federation of Obstetrics and Gynaecology

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“…By Day 4, the daily quantities of ISMN released from the rings had declined to between 8-57 mg, and to 3-25 mg by Day 11. These daily release quantities administered from the rings are of an entirely similar order of magnitude to doses reported previously for vaginal administration of ISMN tablets in both out-patient and in-patient settings (Agarwal et al, 2014(Agarwal et al, , 2012Bollapragada et al, 2009;Bullarbo et al, 2007;Chanrachakul et al, 2002;Habib et al, 2008;Vidanagamage and Goonewardene, 2011). The continuous dosing of ISMN offered by the rings may be clinically more effective and enhance compliance compared to the periodic dosing regimen used for the tablets (48, and 16 h prior to the scheduled time of admission for induction).…”

Section: Release Of Ismn From Vrssupporting

confidence: 60%

“…Although more commonly used for the treatment of angina pectoris, there has also been interest in the use of the nitric oxide donor isosorbide mononitrate (ISMN) for cervical ripening (Agarwal et al, 2014(Agarwal et al, , 2012Bollapragada et al, 2009;Bullarbo et al, 2007;Chanrachakul et al, 2002Chanrachakul et al, , 2000Chwalisz et al, 1997;Habib et al, 2008;Ledingham et al, 2000;Norman, 1996;Tschugguel et al, 1999;Väisänen-Tommiska et al, 2003). In contrast to prostaglandins, nitric oxide donors induce cervical ripening without causing uterine contractions, making them particularly interesting for use in out-patient settings where fetal monitoring is not possible.…”

Section: Introductionmentioning

confidence: 99%

Intravaginal rings for continuous low-dose administration of cervical ripening agents

Wang

Boyd

Hunter³

et al. 2018

International Journal of Pharmaceutics

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Intravaginal rings (VRs) have been widely reported for administration of pharmaceutical drugs - most notably estrogens, progestogens and antiretrovirals - to the vagina for clinical benefit. Here, for the first time, we describe the design, manufacture and preclinical testing of VRs for sustained/controlled release of the cervical ripening agents isosorbide mononitrate (ISMN) and misoprostol (MP), either singly or in combination. Matrix-type silicone elastomer VRs containing ISMN showed declining daily release rates, ranging from 31 to 168 mg (Day 1) to 3-25 mg (Day 11). Novel orifice-type rings, in which a MP-containing silicone elastomer core is partially exposed to the external environment by overmolding with a non-medicated silicone elastomer sheath containing orifices, provided relatively constant daily MP release rates over 14 days (∼20 or 60 μg/day depending on the formulation type). Combination VRs offered simultaneous release of both ISMN and MP over 14 days, with an almost constant MP release rate (60 μg/day) and steadily declining daily ISMN release (295 mg on Day 1 and 24 mg on Day 11). The VR design can be readily tailored to provide sustained or controlled release of ISMN and MP at rates potentially useful for cervical ripening.

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“…[3] Other trials involve use of isosorbide mononitrate and a combination of dinoprostone and oxytocin, but they are not very effective. [4,5] The aim of this study was to compare the safety and efficacy of intracervical dinoprostone gel with that of intravaginal misoprostol tablet as a cervical ripening agent.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the efficacy and safety of intracervical dinoprostone gel and intravaginal misoprostol tablet as a cervical ripening agent

Mukherjee¹,

Mukherjee²

2015

Int J Med Sci Public Health

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Background: Cervical ripening is an important prerequisite for successful induction of labor, a procedure that is frequently necessary because of medical or obstetrical complications. Of several methods of ripening, intracervical dinoprostone gel and intravaginal misoprostol tablet are the most frequently used methods. Aims and Objectives: To compare the efficacy and safety of intracervical dinoprostone gel and intravaginal misoprostol tablet as a cervical ripening agent. Materials and Methods: A total of 138 pregnant women satisfying the inclusion criteria were studied. They were divided into two groups: 72 in group 1 (dinoprostone gel) and 66 in group 2 (misoprostol tablet). The safety and efficacy of both the drugs were analyzed. The primary outcome variables were change in Bishop's score, induction to delivery (I-D) time, Apgar score, and incidence of abnormal uterine action. The secondary outcome variables were need for oxytocin, indication for caesarean section, and mode of delivery. Statistical analysis was done using the unpaired t-test and w 2-test. Results: No difference was observed between the two groups with respect to change in Bishop's score (3.015 vs 3.625, p 4 0.05), but I-D time was more for group 1 (i.e., 15.04 vs 11.48 h, p o 0.05). Apgar scores were also similar in both the groups, that is, the number of babies with Apgar score of o8 at 5 min was 3 for group 1 vs 6 for group 2, p 4 0.05. Abnormal uterine action was not seen at all in group 1, whereas three patients had this problem in group 2. In secondary variables, requirement of oxytocin was more in group 1 (i.e., 48 vs 22, p o 0.05). In various indications of caesarean section, none got operated for abnormal uterine action in group 1, whereas three patients got operated for this reason in group 2. Mode of delivery was similar in both the groups. Conclusions: Dinoprostone and misoprostol are similar in their action on cervical ripening. Misoprostol has an added benefit of being a uterotonic agent. Therefore, it has less I-D time. Low-dose of misoprostol has decreased the incidence of side effects.

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Randomized Comparison of Isosorbide Mononitrate and PGE2 Gel for Cervical Ripening at Term including High Risk Pregnancy

Cited by 9 publications

References 17 publications

Effectiveness of Isosorbide Mononitrate vs Prostaglandin E2 Gel for Cervical Ripening: A Study

Effectiveness of Isosorbide Mononitrate vs Prostaglandin E2 Gel for Cervical Ripening: A Study

Intravaginal rings for continuous low-dose administration of cervical ripening agents

Comparison of the efficacy and safety of intracervical dinoprostone gel and intravaginal misoprostol tablet as a cervical ripening agent

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