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A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days gestation.

Abstract

OBJECTIVES

To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20weeks gestation and to compare side effects of buccal and vaginal misoprostol administration.

STUDY DESIGN

We randomized women undergoing D&E at 14weeks 0days to 19weeks 6days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2x2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps.

RESULTS

We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8min with and without hygroscopic dilators (difference 3.2min, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) minutes longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7mm with and without hygroscopic dilators (difference 3.9mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p=.04.

CONCLUSIONS

Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6h prior to D&E before 20weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol.

IMPLICATIONS

Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.

Authors+Show Affiliations

MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010. Electronic address: jmshakir@gmail.com.MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010.Planned Parenthood of Metropolitan Washington, DC, 1225 4(th). St., NE, Washington, DC 20002.MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010; Georgetown University School of Medicine, 4000 Reservoir Rd NW, 120 Building D, Washington, DC 20007.MedStar Washington Hospital Center, 106 Irving St., Suite 4700, Washington, DC 20010; DuPont Clinic, 1120 19(th) St. NW, Suite 316, Washington, DC 20036; Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St. Baltimore, MD 21205.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31520608

Citation

Shakir-Reese, Jamilah M., et al. "A Factorial-design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-day Cervical Preparation Prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days Gestation." Contraception, 2019.
Shakir-Reese JM, Ye PP, Perritt JB, et al. A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days gestation. Contraception. 2019.
Shakir-Reese, J. M., Ye, P. P., Perritt, J. B., Lotke, P. S., & Reeves, M. F. (2019). A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days gestation. Contraception, doi:10.1016/j.contraception.2019.09.001.
Shakir-Reese JM, et al. A Factorial-design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-day Cervical Preparation Prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days Gestation. Contraception. 2019 Sep 11; PubMed PMID: 31520608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to Dilation & Evacuation at 14weeks 0days to 19weeks 6days gestation. AU - Shakir-Reese,Jamilah M, AU - Ye,Peggy P, AU - Perritt,Jamila B, AU - Lotke,Pamela S, AU - Reeves,Matthew F, Y1 - 2019/09/11/ PY - 2019/01/11/received PY - 2019/09/04/revised PY - 2019/09/04/accepted PY - 2019/9/15/entrez PY - 2019/9/15/pubmed PY - 2019/9/15/medline KW - Cervical preparation KW - Dilation and evacuation KW - Misoprostol KW - Osmotic dilators KW - Second-trimester abortion KW - Surgical abortion JF - Contraception JO - Contraception N2 - OBJECTIVES: To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20weeks gestation and to compare side effects of buccal and vaginal misoprostol administration. STUDY DESIGN: We randomized women undergoing D&E at 14weeks 0days to 19weeks 6days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2x2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps. RESULTS: We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8min with and without hygroscopic dilators (difference 3.2min, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) minutes longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7mm with and without hygroscopic dilators (difference 3.9mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p=.04. CONCLUSIONS: Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6h prior to D&E before 20weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol. IMPLICATIONS: Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/31520608/A_factorial-design_randomized_controlled_trial_comparing_misoprostol_alone_to_Dilapan_with_misoprostol_and_comparing_buccal_to_vaginal_misoprostol_for_same-day_cervical_preparation_prior_to_Dilation__Evacuation_at_14weeks_0days_to_19weeks_6days_gestation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(19)30413-5 DB - PRIME DP - Unbound Medicine ER -