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Laminaria compared to Dilapan-S for cervical preparation

Ila Dayananda, Planned Parenthood of New York City, Inc, 2013

Project abstract

Adequate cervical preparation before second trimester abortion by dilation and evacuation (D&E) has been shown to reduce the risk of complications. Osmotic dilators have been the standard method of pre-operative cervical ripening for decades. Laminaria and Dilapan-S™ are both widely used. Dilapan-S™ provides more dilation than the same size laminaria and achieves dilation at a faster pace. However, it is currently unknown if either of these osmotic dilators is superior for overnight cervical ripening because there are no randomized trials comparing Laminaria and Dilapan-S™ for this use.

We propose to conduct a double-blind randomized controlled trial comparing overnight cervical preparation with laminaria and Dilapan-S™ before D&E at 18 0/7—24 0/7 weeks of gestation. Our primary outcome is D&E procedure time. Secondary outcomes include number of osmotic dilators placed, cervical dilation, ability to complete the D&E on first attempt, need for mechanical dilation and ease of dilation if required, complications, pain, side effects and provider and patient acceptability. We hypothesize that procedure time will be less in the group that is randomized to Dilapan-S™. To have 80% power to detect a 2 minute difference in procedure time in each gestational age cohort with a 0.05 alpha error, we require a total sample of N=160. If we estimate 10% missing/incomplete data our sample size becomes N=180: 90 subjects between 18 0/7—20 6/7 weeks (45 in each arm) and 90 subjects between 21 0/7—24 0/7 weeks (45 in each arm). The information gathered from this study will address the knowledge gap about osmotic dilator selection for cervical preparation prior to D&E and will inform practice guidelines for second trimester abortion provision.

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