A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination

NCT ID: NCT00310921

Last Updated: 2007-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2006-05-31

Brief Summary

The purpose of this study is to determine whether misoprostol administered prior to elective first trimester pregnancy has an effect on pain and ease of procedure and complications.

Detailed Description

Previous studies suggest that cervical priming with misoprostol may facilitate vacuum aspiration for first trimester termination by inducing cervical dilation. This medication is used routinely at some abortion clinics, not at all at others and is used sporadically at most Kaiser facilities. The present study is designed to investigate whether the use of misoprostol noticeably improves the clinical experience. We will determine whether use of misoprostol compared with placebo during first trimester abortion 1) positively impacts ratings of pain experienced by the patient, 2) positively impacts physicians' ratings regarding difficulty of the procedure, and 3) reduces complications.

Misoprostol is effective for cervical priming prior to vacuum aspiration for first trimester pregnancy termination.2 Previous studies examined dose3,4, route of administration (oral5 or vaginal6,7) and time interval to allow maximum dilation while limiting side effects and bleeding prior to procedure.8,9,10 There is evidence supporting a specific dose, route and time interval.10 Previous studies also examined amount of bleeding, length of procedure, force used to dilate the cervix, and cervical dilation in mm.10 However, it is unknown whether these statistically significant changes translate into clinically relevant changes. For example, Ngai et al.10 report that the blood loss is significantly decreased. However, the mean blood loss differed at most by 68 ml. It is widely accepted that during surgical procedures a difference of 68 ml of blood will not change the patient's hematocrit or postoperative clinical course. In the same study preoperative baseline cervical dilation was only 1.7 mm different, also found to be statistically significant but there is no evidence that this difference changes the clinical experience for either the physician or the patient. All previous studies reviewed were also performed with the patient under general anesthesia so the patient's perception of pain was not examined. Because the majority of first trimester terminations in the U.S. are done with the patient awake, it is important to consider pain.

Conditions

Abortion, Therapeutic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Misoprostol

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Subject must not have a physical or mental health condition which could be adversely affected by the study drug, including a history of allergy to prostaglandins or, specifically, to misoprostol.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Principal Investigators

Seth Feigenbaum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Medical Group, Inc.

Locations

Kaiser Permanente, Department of OB/GYN

San Francisco, California, United States

Countries

United States

Other Identifiers

CN-00SFeig-04-B

Identifier Type: -

Identifier Source: org_study_id