Outpatient vaginal administration of the nitric oxide donor isosorbide mononitrate for cervical ripening and labor induction postterm: a randomized controlled study

Bullarbo, Maria; Orrskog, Monica Eriksson; Andersch, Björn; Granström, Lena; Norström, Anders; Ekerhovd, Erling

doi:10.1016/j.ajog.2006.08.034

Cited by 50 publications

(62 citation statements)

References 22 publications

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“…This aspect has not been assessed in other studies. There was no significant differences in mode of delivery, duration of labour and oxytocin requirements during labour in the ISMN treated group, and this is comparable to the findings of previous studies [18][19][20]. The mean induction delivery intervals in the current study were markedly shorter than in the IMOP study and this may be due to the majority of women in the IMOP study having epidural analgesia during labour and the relatively high doses of oxytocin used for IOL in the academic obstetric unit of THMG.…”

Section: Discussionsupporting

confidence: 81%

“…Therefore outcome measures such as time to vaginal delivery and vaginal delivery not achieved in 24 hours, used for assessment of therapies for IOL, are not appropriate for studies on vaginally administered NO donors. The main advantage [18][19][20]. However in our unit women often self admit themselves to hospital within a day or two of completion of 40 weeks gestation if they have not established SOL.…”

Section: Discussionmentioning

confidence: 99%

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Cervical ripening with self administered iso sorbide mononitrate vaginally, in uncomplicated singleton pregnancies at 39 weeks gestation: a double blind randomised controlled trial

Attanayake¹,

Goonewardene²

2016

Ceylon Med. J.

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Introduction Vaginal iso sorbide mononitrate (ISMN) is effective in pre induction cervical ripening in post dated pregnancies.Objectives To determine the effectiveness and acceptability of ISMN self-administered vaginally at home, in causing cervical ripening in uncomplicated singleton pregnancies at 39 weeks gestation.Methods Consecutive women with uncomplicated singleton pregnancies, presenting between 01 October 2013 and 31 March 2014, with a modified Bishop score (MBS) of < 5 at a gestational age (GA) of 273 days to the University Obstetric Unit of Teaching Hospital Mahamodera Galle, were allocated by stratified (primip/multip) block randomisation to self-administer vaginally at home every other day, five doses of 60 mg of sustained release form of ISMN (ISMN-SR); (n = 72, cases), or pyridoxine 10 mgs (n=72, controls), from GA 273 to 282 days. ResultsThe mean MBS and the mean change of MBS at 282 days, and the proportions with spontaneous onset of labour (SOL) by GA 282 days, were not significantly different between the two groups. A vast majority were satisfied with outpatient therapy (80% cases vs.76% controls), were happy to use it in a subsequent preg-nancy (89% cases vs. 86% controls) and would recom-mend it to a friend (93% cases vs. 90% controls).Conclusions Home adminstrated vaginal ISMN therapy from GA 39 weeks was not effective in causing significant cervical ripening or promoting SOL, but it was acceptable to women.Cervical ripening with self administered iso sorbide mononitrate vaginally, in uncomplicated singleton pregnancies at 39 weeks gestation: a double blind randomised controlled trial This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

Cervical ripening with self administered iso sorbide mononitrate vaginally, in uncomplicated singleton pregnancies at 39 weeks gestation: a double blind randomised controlled trial

Attanayake¹,

Goonewardene²

2016

Ceylon Med. J.

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“…Although prostaglandins are more effective than ISMN, outpatient use of prostaglandins carries a high risk and is not recommended. Recent studies have demonstrated that ISMN could be safely self administered by women on an outpatient basis [20,21]. The women who participated in these studies had greater maternal satisfaction and were very positive about the opportunity to undertake cervical ripening at home.…”

Section: Introductionmentioning

confidence: 99%

The efficacy of two different doses of vaginal isosorbide mononitrate in pre induction cervical ripening: a double blind randomised controlled trial

Vidanagamage

Goonewardene

2011

Ceylon Med. J.

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Objective Nitric oxide donors have been shown to cause cervical ripening. The aim of this study was to evaluate the effects on the mother and the fetus when isosorbide mononitrate (ISMN) 40 mg or the sustained release ISMN (ISMN -SR) 60 mg was administered vaginally for preinduction cervical ripening.Methods A double blind randomised controlled trial. Consecutive women (n=156) with uncomplicated singleton pregnancies between 40 weeks +5 days and 41 weeks' gestation with modified Bishop Scores (MBS) <5 were allocated by stratified (primp / multip) block randomisation to receive ISMN 40 mg, ISMN -SR 60 mg or the placebo vitamin C 100 mg vaginally.Results At the commencement of the study the parity and mean age, MBS, pulse rate (PR), systolic and diastolic blood pressure (SBP and DBP), umbilical artery resistance index (RI) and pulsatility index (PI) were similar among the three treatment groups. There was significant increase (p<0.001) of mean MBS by 1.3 (95% CI 0.8, 1.7) in primips and by 1.7 (95% CI 1.3, 2.0) in multips at 6 hours and by 2.4 (95% CI 1.9, 2.7 ) in primips and by 2.3 (95% CI 2.0, 2.6) in multips at 48 hours. Greater proportions of primips (42% with ISMN -SR 60 mg and 31% with ISMN 40 mg, p<0.05) were favourable for induction of labour (IOL) after 48 hours in comparison with the controls (7.6%). Greater proportions of multips (46% with ISMN -SR 60 mg and 40% with ISMN 40 mg, p<0.05) were favourable for IOL after 48 hours in comparison with the controls (16%). A mean increase of PR by 6.7-10.2 bpm (95% CI 5.0 -12.5, p<0.001) in both ISMN groups at 180 minutes persisted up to 360 minutes. A mean reduction of SBP by 7.3 -10 mmHg (95% CI = 8.0-11.5, p<0.001) in both ISMN groups at 180 minutes persisted up to 360 mins. No significant change was seen in DBP, RI or PI. Frequency of maternal side effects (mainly headache) were higher in ISMN groups. Conclusions

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“…Only two studies Bullarbo 2007) collected information on women's views about the induction process, and overall there was very little …”

Section: Summary Of Main Resultsmentioning

confidence: 99%

“…Four trials used sealed, opaque, sequentially numbered envelopes to conceal allocation (Bullarbo 2007;Harper 2006;Larmon 2002;; envelopes were also used in the Meyer 2005 and Stenlund 1999 trials, although in the former it was not stated that they were sealed, and in the latter that they were opaque. In six trials methods to conceal group allocation were not clear (Elliott 1998;Gittens 1996;Hage 1993;Lyons 2001;Newman 1997;Sawai 1991).…”

Section: Risk Of Bias In Included Studiesmentioning

confidence: 99%

Different methods for the induction of labour in outpatient settings

Kelly

Alfirević

Norman

et al. 2009

Cochrane Database of Systematic Reviews

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Outpatient vaginal administration of the nitric oxide donor isosorbide mononitrate for cervical ripening and labor induction postterm: a randomized controlled study

Cited by 50 publications

References 22 publications

Cervical ripening with self administered iso sorbide mononitrate vaginally, in uncomplicated singleton pregnancies at 39 weeks gestation: a double blind randomised controlled trial

Cervical ripening with self administered iso sorbide mononitrate vaginally, in uncomplicated singleton pregnancies at 39 weeks gestation: a double blind randomised controlled trial

The efficacy of two different doses of vaginal isosorbide mononitrate in pre induction cervical ripening: a double blind randomised controlled trial

Different methods for the induction of labour in outpatient settings

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