Mifepristone and Misoprostol as Effective as Osmotic Dilation for Second-Trimester Termination

Summary

This article presents results from a prospective randomized clinical trial demonstrating that when compared with mechanical methods, pharmacologic cervical preparation does not prolong procedure times in patients undergoing surgical evacuation of second-trimester pregnancies and is acceptable to both operators and patients [Paris AE et al. Obstet Gynecol 2014].

  • Obstetrics & Gynecology Clinical Trials
  • Pregnancy
  • Diagnostic & Surgical Procedures
  • Obstetrics & Gynecology
  • Obstetrics & Gynecology Clinical Trials
  • Pregnancy
  • Diagnostic & Surgical Procedures

Amy E. Paris, MD, Boston University School of Medicine, Boston, Massachusetts, USA, presented results from a prospective randomized clinical trial demonstrating that when compared with mechanical methods, pharmacologic cervical preparation does not prolong procedure times in patients undergoing surgical evacuation of second-trimester pregnancies and is acceptable to both operators and patients [Paris AE et al. Obstet Gynecol 2014].

Cervical preparation is recommended before surgical evacuation of second-trimester pregnancies, and in the United States, it is achieved via mechanical methods (osmotic dilators [ODs]), pharmacologic agents (misoprostol and mifepristone), or a combination of both techniques [Fox. Contraception 2014; Newmann. Cochrane Database Syst Rev 2010]. Mifepristone is considered more effective than misoprostol for first-trimester surgical abortion and between 14 and 16 weeks of gestation, but it is noninferior to ODs with respect to procedure time [Borgatta L et al. Contraception 2012; Kapp N et al. Cochrane Database Syst Rev 2010; Carbonnel JL et al. Contraception 2007]. The combination of mifepristone and misoprostol may also effectively permit evacuation, and it has been shown to be more effective than misoprostol alone for second-trimester surgical abortion.

Although prostaglandins and ODs have been used and studied as cervical preparations before second-trimester surgical abortion, there is no consensus as to which method is superior with regard to safety, procedure time, need for additional dilation, ability to perform the procedure, or patient and physician acceptability [Newmann SJ et al. Cochrane Database Syst Rev 2010]. With this in mind, Prof. Paris and colleagues conducted a randomized controlled study to compare the efficacy of pharmacologic versus mechanical cervical preparation before surgical evacuation at 15 to 18 weeks.

The primary endpoint of the study was total abortion time (from insertion of the speculum to its removal) and total operative time. Secondary outcomes were operator-and patient-related experiences.

Fifty women (age, 18 to 45 years; gestational age, 15 to 18 weeks) undergoing surgical abortion were prospectively and randomly assigned to 2 cervical preparation groups. Baseline characteristics were similar in both groups (mean age, 26 years; mean gestational age, 16±2 weeks; 30% were nulliparous; 20% had undergone a previous second-trimester surgical abortion via ODs).

Women in the pharmacologic preparation group received mifepristone (200 mg, orally) 24 hours before the procedure and misoprostol (400 μg, buccally) 2 hours before. Those in the mechanical preparation group underwent OD insertion 24 hours before the procedure.

There was no difference between the pharmacologic and OD groups in the primary outcome of median total abortion time (13.5 vs 14.0 minutes; p=0.99) and operative time (from intrauterine instrumentation to speculum removal; 7.0 vs 8.5 minutes; p=0.51).

With respect to secondary outcomes, physicians rated the ease of procedure similarly for both methods. However, women in the OD group reported more discomfort overnight and indicated that they would prefer mifepristone if they ever needed another procedure.

Prof. Paris concluded that the use of mifepristone, followed by misoprostol, for cervical preparation is as effective as overnight ODs for cervical preparation before surgical abortion for up to 18 weeks and does not result in longer procedure times. She also stated that women prefer the pharmacologic preparation method because it is associated with less procedural discomfort.

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