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Research
Daniele Sofia de Moraes Barros Gattas
Instituto de Medicina Integral Professor Fernando Figueira
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9968-6193
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This work is licensed under a CC BY 4.0 License. Read Full License
Background: Labor induction is defined as any procedure that stimulates uterine contractions before labor begins spontaneously. The vaginal and oral routes of administration of misoprostol are those most used for the induction of labor in routine practice, with the recommended dose being 25 μg. Nevertheless, the sublingual route may reduce the number of vaginal examinations required, increasing patient comfort and lowering the risk of maternal and fetal infection. Based on a previous systematic review, the objective of this study was to compare the frequency of tachysystole as the main outcome measure when misoprostol is administered sublingually at the dose of 12.5μg versus vaginally at a dose of 25μg to induce labor in a full-term pregnancy with a live fetus.
Methods: A randomized, placebo-controlled, triple-blind clinical trial was conducted at two maternity hospitals in northeastern Brazil. Two hundred patients with a full-term pregnancy, a live fetus, Bishop score ≤6 and an indication for induction of labor were included. Following randomization, one group received 12.5μg misoprostol sublingually and a vaginal placebo, while the other group received a sublingual placebo and 25μg misoprostol vaginally. The primary outcome was the frequency of tachysystole. Student’s t-test, the chi-square test of association and Fisher’s exact test were used, as appropriate. Risk ratios and their 95% confidence intervals were calculated. Results: The frequency of tachysystole was lower in the group using 12.5μg misoprostol sublingually compared to the group using 25μg misoprostol vaginally (RR=0.15; 95%CI: 0.02-0.97; p=0.002). Failure to achieve vaginal delivery within 12 and 24 hours was similar in both groups. Sublingual administration was preferred to vaginal administration by women in both groups; however, the difference was not statistically significant.
Conclusion: The effectiveness of labor induction with low-dose sublingual misoprostol was similar to that achieved with vaginal administration of the recommended dose; however, the rate of tachysystole was lower in the sublingual group, and this route of administration may prove a safe alternative.
Trial registration: Registration number: NCT01406392, ClinicalTrials.gov. Date of registration: August 1, 2011.
Keywords
Administration, sublingual, Clinical trial, Labor, induced, Labor, obstetric, Misoprostol/administration & dosage, Multicenter study
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CURRENT STATUS: Published
View the published article at Reproductive Health.
Version 2
Posted 19 Mar, 2020
No community comments so far
Editorial decision: Accept
On 26 Mar, 2020
Editor assigned
On 16 Mar, 2020
Submission checks complete
On 15 Mar, 2020
Editor invited
On 15 Mar, 2020
No comments provided
Editorial decision: Accept but Needs Editing
On 18 Feb, 2020
Review #2 received
Received 14 Feb, 2020
Review #1 received
Received 13 Feb, 2020
Reviewer #2 agreed
On 27 Jan, 2020
Reviewer #1 agreed
On 20 Jan, 2020
Reviewers invited
Invitations sent on 17 Jan, 2020
First submitted
On 07 Jan, 2020
Editor assigned
On 07 Jan, 2020
Submission checks complete
On 06 Jan, 2020
Editor invited
On 06 Jan, 2020
Metrics
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PDF Downloads: ...
HTML Views: ...
Subject Areas
Sexual & Reproductive Medicine
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A new preprint design is coming!
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See the published version of this preprint at Reproductive Health.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Daniele Sofia de Moraes Barros Gattas
Instituto de Medicina Integral Professor Fernando Figueira
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9968-6193
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Reproductive Health.
Version 2
Posted 19 Mar, 2020
No community comments so far
Editorial decision: Accept
On 26 Mar, 2020
Editor assigned
On 16 Mar, 2020
Submission checks complete
On 15 Mar, 2020
Editor invited
On 15 Mar, 2020
No comments provided
Editorial decision: Accept but Needs Editing
On 18 Feb, 2020
Review #2 received
Received 14 Feb, 2020
Review #1 received
Received 13 Feb, 2020
Reviewer #2 agreed
On 27 Jan, 2020
Reviewer #1 agreed
On 20 Jan, 2020
Reviewers invited
Invitations sent on 17 Jan, 2020
First submitted
On 07 Jan, 2020
Editor assigned
On 07 Jan, 2020
Submission checks complete
On 06 Jan, 2020
Editor invited
On 06 Jan, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Sexual & Reproductive Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Reproductive Health.
Background: Labor induction is defined as any procedure that stimulates uterine contractions before labor begins spontaneously. The vaginal and oral routes of administration of misoprostol are those most used for the induction of labor in routine practice, with the recommended dose being 25 μg. Nevertheless, the sublingual route may reduce the number of vaginal examinations required, increasing patient comfort and lowering the risk of maternal and fetal infection. Based on a previous systematic review, the objective of this study was to compare the frequency of tachysystole as the main outcome measure when misoprostol is administered sublingually at the dose of 12.5μg versus vaginally at a dose of 25μg to induce labor in a full-term pregnancy with a live fetus.
Methods: A randomized, placebo-controlled, triple-blind clinical trial was conducted at two maternity hospitals in northeastern Brazil. Two hundred patients with a full-term pregnancy, a live fetus, Bishop score ≤6 and an indication for induction of labor were included. Following randomization, one group received 12.5μg misoprostol sublingually and a vaginal placebo, while the other group received a sublingual placebo and 25μg misoprostol vaginally. The primary outcome was the frequency of tachysystole. Student’s t-test, the chi-square test of association and Fisher’s exact test were used, as appropriate. Risk ratios and their 95% confidence intervals were calculated. Results: The frequency of tachysystole was lower in the group using 12.5μg misoprostol sublingually compared to the group using 25μg misoprostol vaginally (RR=0.15; 95%CI: 0.02-0.97; p=0.002). Failure to achieve vaginal delivery within 12 and 24 hours was similar in both groups. Sublingual administration was preferred to vaginal administration by women in both groups; however, the difference was not statistically significant.
Conclusion: The effectiveness of labor induction with low-dose sublingual misoprostol was similar to that achieved with vaginal administration of the recommended dose; however, the rate of tachysystole was lower in the sublingual group, and this route of administration may prove a safe alternative.
Trial registration: Registration number: NCT01406392, ClinicalTrials.gov. Date of registration: August 1, 2011.
This is a list of supplementary files associated with this preprint. Click to download.
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