Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.

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Title: Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.
Authors: Mundle, Shuchita, Lightly, Kate, Durocher, Jill, Bracken, Hillary, Tadas, Moushmi, Parvekar, Seema, Shivkumar, Poonam Varma, Faragher, Brian, Easterling, Thomas, Leigh, Simon, Turner, Mark, Alfirevic, Zarko, Winikoff, Beverly, Weeks, Andrew D.
Source: BJOG: An International Journal of Obstetrics & Gynaecology; Oct2024, Vol. 131 Issue 11, p1532-1544, 13p
Subject Terms: FETAL monitoring, FETAL heart rate, HYPERTENSION in pregnancy, INDUCED labor (Obstetrics), NEONATAL death, UTERINE rupture, PREMATURE rupture of fetal membranes
Geographic Terms: INDIA
Abstract: Objective: To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low‐dose oral misoprostol is superior to intravenous oxytocin. Design: Open‐label, superiority randomised trial. Setting: Government hospitals in India. Population: Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture. Methods: Participants received misoprostol (25 micrograms, orally, 2‐hourly) or titrated oxytocin through an infusion pump. All women had one‐to‐one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring. Main outcome measures: Caesarean birth. Results: A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81–1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207–244 min, vs 194 min, 179–210 min; aOR 1.137; 95% CI 1.023–1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203–1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups. Conclusions: Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial. [ABSTRACT FROM AUTHOR]
Copyright of BJOG: An International Journal of Obstetrics & Gynaecology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.
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  Data: <searchLink fieldCode="AR" term="%22Mundle%2C+Shuchita%22">Mundle, Shuchita</searchLink><br /><searchLink fieldCode="AR" term="%22Lightly%2C+Kate%22">Lightly, Kate</searchLink><br /><searchLink fieldCode="AR" term="%22Durocher%2C+Jill%22">Durocher, Jill</searchLink><br /><searchLink fieldCode="AR" term="%22Bracken%2C+Hillary%22">Bracken, Hillary</searchLink><br /><searchLink fieldCode="AR" term="%22Tadas%2C+Moushmi%22">Tadas, Moushmi</searchLink><br /><searchLink fieldCode="AR" term="%22Parvekar%2C+Seema%22">Parvekar, Seema</searchLink><br /><searchLink fieldCode="AR" term="%22Shivkumar%2C+Poonam+Varma%22">Shivkumar, Poonam Varma</searchLink><br /><searchLink fieldCode="AR" term="%22Faragher%2C+Brian%22">Faragher, Brian</searchLink><br /><searchLink fieldCode="AR" term="%22Easterling%2C+Thomas%22">Easterling, Thomas</searchLink><br /><searchLink fieldCode="AR" term="%22Leigh%2C+Simon%22">Leigh, Simon</searchLink><br /><searchLink fieldCode="AR" term="%22Turner%2C+Mark%22">Turner, Mark</searchLink><br /><searchLink fieldCode="AR" term="%22Alfirevic%2C+Zarko%22">Alfirevic, Zarko</searchLink><br /><searchLink fieldCode="AR" term="%22Winikoff%2C+Beverly%22">Winikoff, Beverly</searchLink><br /><searchLink fieldCode="AR" term="%22Weeks%2C+Andrew+D%2E%22">Weeks, Andrew D.</searchLink>
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  Data: BJOG: An International Journal of Obstetrics & Gynaecology; Oct2024, Vol. 131 Issue 11, p1532-1544, 13p
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  Data: <searchLink fieldCode="DE" term="%22FETAL+monitoring%22">FETAL monitoring</searchLink><br /><searchLink fieldCode="DE" term="%22FETAL+heart+rate%22">FETAL heart rate</searchLink><br /><searchLink fieldCode="DE" term="%22HYPERTENSION+in+pregnancy%22">HYPERTENSION in pregnancy</searchLink><br /><searchLink fieldCode="DE" term="%22INDUCED+labor+%28Obstetrics%29%22">INDUCED labor (Obstetrics)</searchLink><br /><searchLink fieldCode="DE" term="%22NEONATAL+death%22">NEONATAL death</searchLink><br /><searchLink fieldCode="DE" term="%22UTERINE+rupture%22">UTERINE rupture</searchLink><br /><searchLink fieldCode="DE" term="%22PREMATURE+rupture+of+fetal+membranes%22">PREMATURE rupture of fetal membranes</searchLink>
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  Group: Su
  Data: <searchLink fieldCode="DE" term="%22INDIA%22">INDIA</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Objective: To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low‐dose oral misoprostol is superior to intravenous oxytocin. Design: Open‐label, superiority randomised trial. Setting: Government hospitals in India. Population: Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture. Methods: Participants received misoprostol (25 micrograms, orally, 2‐hourly) or titrated oxytocin through an infusion pump. All women had one‐to‐one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring. Main outcome measures: Caesarean birth. Results: A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81–1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207–244 min, vs 194 min, 179–210 min; aOR 1.137; 95% CI 1.023–1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203–1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups. Conclusions: Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of BJOG: An International Journal of Obstetrics & Gynaecology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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RecordInfo BibRecord:
  BibEntity:
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      – Type: doi
        Value: 10.1111/1471-0528.17839
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 13
        StartPage: 1532
    Subjects:
      – SubjectFull: INDIA
        Type: general
      – SubjectFull: FETAL monitoring
        Type: general
      – SubjectFull: FETAL heart rate
        Type: general
      – SubjectFull: HYPERTENSION in pregnancy
        Type: general
      – SubjectFull: INDUCED labor (Obstetrics)
        Type: general
      – SubjectFull: NEONATAL death
        Type: general
      – SubjectFull: UTERINE rupture
        Type: general
      – SubjectFull: PREMATURE rupture of fetal membranes
        Type: general
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      – TitleFull: Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.
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            – D: 01
              M: 10
              Text: Oct2024
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