Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation: a randomized controlled trial

Christy M. Boraas, Sharon L. Achilles, Miriam L. Cremer, Catherine A. Chappell, Sarah E. Lim, Beatrice A. Chen

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective This study aims to evaluate buccal misoprostol as an adjunct to synthetic osmotic dilators for same-day dilation and evacuation (D&E). Study design A randomized, double-blinded, placebo-controlled trial of women 16 0/7 to 20 6/7 weeks gestation desiring D&E was used. Participants received synthetic osmotic cervical dilators (Dilapan-S®) at least 4 h prior to D&E and were randomized to 400 mcg buccal misoprostol or placebo 3 h preoperatively, stratified by gestational age. The primary outcome was operative time with 36 participants needed to detect a 4-min difference (two-sided α = 0.05, 80% power). Secondary outcomes included total procedure time, patient and provider acceptability, baseline cervical dilation and complications. Results Twenty-nine women were enrolled (misoprostol n = 14, placebo n = 15) and mean operative time was similar between the groups (11.1 vs. 13.5 min, respectively, p = .17). Complications were nonsignificantly more common for participants ≥ 19 weeks compared to < 19 weeks (22% vs. 9%, p = .62) and those who received placebo compared to misoprostol (27% vs. 7%, p = .33). Two serious adverse events in the placebo group prompted early study closure for safety and futility. Placebo participants had longer overall procedure times (24 vs. 18 min, p = .03) and less cramping preoperatively (p < .01) but similar results for other secondary outcomes compared to those receiving misoprostol. Women strongly preferred same-day cervical preparation (98%). Conclusions Adjunctive buccal misoprostol may not decrease operative times but may decrease complications when combined with synthetic osmotic dilators for cervical preparation for same-day D&E procedures. Implications Although the trial was halted early and underpowered to make conclusions about the primary outcome, complication frequency and type warrant caution for use of synthetic osmotic dilators alone for cervical preparation for same-day D&E at ≥ 19 weeks gestation.

Original languageEnglish (US)
Pages (from-to)467-472
Number of pages6
JournalContraception
Volume94
Issue number5
DOIs
StatePublished - Nov 1 2016

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Misoprostol
Dilatation
Randomized Controlled Trials
Placebos
Cheek
Operative Time
Medical Futility
Pregnancy
Gestational Age
Safety

Keywords

  • Abortion, induced
  • Dilation and evacuation
  • Misoprostol
  • Second trimester

Cite this

Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation : a randomized controlled trial. / Boraas, Christy M.; Achilles, Sharon L.; Cremer, Miriam L.; Chappell, Catherine A.; Lim, Sarah E.; Chen, Beatrice A.

In: Contraception, Vol. 94, No. 5, 01.11.2016, p. 467-472.

Research output: Contribution to journalArticle

Boraas, Christy M. ; Achilles, Sharon L. ; Cremer, Miriam L. ; Chappell, Catherine A. ; Lim, Sarah E. ; Chen, Beatrice A. / Synthetic osmotic dilators with adjunctive misoprostol for same-day dilation and evacuation : a randomized controlled trial. In: Contraception. 2016 ; Vol. 94, No. 5. pp. 467-472.
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abstract = "Objective This study aims to evaluate buccal misoprostol as an adjunct to synthetic osmotic dilators for same-day dilation and evacuation (D&E). Study design A randomized, double-blinded, placebo-controlled trial of women 16 0/7 to 20 6/7 weeks gestation desiring D&E was used. Participants received synthetic osmotic cervical dilators (Dilapan-S{\circledR}) at least 4 h prior to D&E and were randomized to 400 mcg buccal misoprostol or placebo 3 h preoperatively, stratified by gestational age. The primary outcome was operative time with 36 participants needed to detect a 4-min difference (two-sided α = 0.05, 80{\%} power). Secondary outcomes included total procedure time, patient and provider acceptability, baseline cervical dilation and complications. Results Twenty-nine women were enrolled (misoprostol n = 14, placebo n = 15) and mean operative time was similar between the groups (11.1 vs. 13.5 min, respectively, p = .17). Complications were nonsignificantly more common for participants ≥ 19 weeks compared to < 19 weeks (22{\%} vs. 9{\%}, p = .62) and those who received placebo compared to misoprostol (27{\%} vs. 7{\%}, p = .33). Two serious adverse events in the placebo group prompted early study closure for safety and futility. Placebo participants had longer overall procedure times (24 vs. 18 min, p = .03) and less cramping preoperatively (p < .01) but similar results for other secondary outcomes compared to those receiving misoprostol. Women strongly preferred same-day cervical preparation (98{\%}). Conclusions Adjunctive buccal misoprostol may not decrease operative times but may decrease complications when combined with synthetic osmotic dilators for cervical preparation for same-day D&E procedures. Implications Although the trial was halted early and underpowered to make conclusions about the primary outcome, complication frequency and type warrant caution for use of synthetic osmotic dilators alone for cervical preparation for same-day D&E at ≥ 19 weeks gestation.",
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AU - Boraas, Christy M.

AU - Achilles, Sharon L.

AU - Cremer, Miriam L.

AU - Chappell, Catherine A.

AU - Lim, Sarah E.

AU - Chen, Beatrice A.

PY - 2016/11/1

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N2 - Objective This study aims to evaluate buccal misoprostol as an adjunct to synthetic osmotic dilators for same-day dilation and evacuation (D&E). Study design A randomized, double-blinded, placebo-controlled trial of women 16 0/7 to 20 6/7 weeks gestation desiring D&E was used. Participants received synthetic osmotic cervical dilators (Dilapan-S®) at least 4 h prior to D&E and were randomized to 400 mcg buccal misoprostol or placebo 3 h preoperatively, stratified by gestational age. The primary outcome was operative time with 36 participants needed to detect a 4-min difference (two-sided α = 0.05, 80% power). Secondary outcomes included total procedure time, patient and provider acceptability, baseline cervical dilation and complications. Results Twenty-nine women were enrolled (misoprostol n = 14, placebo n = 15) and mean operative time was similar between the groups (11.1 vs. 13.5 min, respectively, p = .17). Complications were nonsignificantly more common for participants ≥ 19 weeks compared to < 19 weeks (22% vs. 9%, p = .62) and those who received placebo compared to misoprostol (27% vs. 7%, p = .33). Two serious adverse events in the placebo group prompted early study closure for safety and futility. Placebo participants had longer overall procedure times (24 vs. 18 min, p = .03) and less cramping preoperatively (p < .01) but similar results for other secondary outcomes compared to those receiving misoprostol. Women strongly preferred same-day cervical preparation (98%). Conclusions Adjunctive buccal misoprostol may not decrease operative times but may decrease complications when combined with synthetic osmotic dilators for cervical preparation for same-day D&E procedures. Implications Although the trial was halted early and underpowered to make conclusions about the primary outcome, complication frequency and type warrant caution for use of synthetic osmotic dilators alone for cervical preparation for same-day D&E at ≥ 19 weeks gestation.

AB - Objective This study aims to evaluate buccal misoprostol as an adjunct to synthetic osmotic dilators for same-day dilation and evacuation (D&E). Study design A randomized, double-blinded, placebo-controlled trial of women 16 0/7 to 20 6/7 weeks gestation desiring D&E was used. Participants received synthetic osmotic cervical dilators (Dilapan-S®) at least 4 h prior to D&E and were randomized to 400 mcg buccal misoprostol or placebo 3 h preoperatively, stratified by gestational age. The primary outcome was operative time with 36 participants needed to detect a 4-min difference (two-sided α = 0.05, 80% power). Secondary outcomes included total procedure time, patient and provider acceptability, baseline cervical dilation and complications. Results Twenty-nine women were enrolled (misoprostol n = 14, placebo n = 15) and mean operative time was similar between the groups (11.1 vs. 13.5 min, respectively, p = .17). Complications were nonsignificantly more common for participants ≥ 19 weeks compared to < 19 weeks (22% vs. 9%, p = .62) and those who received placebo compared to misoprostol (27% vs. 7%, p = .33). Two serious adverse events in the placebo group prompted early study closure for safety and futility. Placebo participants had longer overall procedure times (24 vs. 18 min, p = .03) and less cramping preoperatively (p < .01) but similar results for other secondary outcomes compared to those receiving misoprostol. Women strongly preferred same-day cervical preparation (98%). Conclusions Adjunctive buccal misoprostol may not decrease operative times but may decrease complications when combined with synthetic osmotic dilators for cervical preparation for same-day D&E procedures. Implications Although the trial was halted early and underpowered to make conclusions about the primary outcome, complication frequency and type warrant caution for use of synthetic osmotic dilators alone for cervical preparation for same-day D&E at ≥ 19 weeks gestation.

KW - Abortion, induced

KW - Dilation and evacuation

KW - Misoprostol

KW - Second trimester

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