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

This study has been completed.
Sponsor:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00310921
First received: April 3, 2006
Last updated: April 10, 2007
Last verified: November 2005
  Purpose

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.


Condition Intervention Phase
Abortion, Therapeutic
Drug: Misoprostol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Study of Cervical Priming With Misoprostol Prior to Elective First Trimester Pregnancy Termination: Effects on Pain, Ease of Procedure and Complications

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • The first assessment will be a Visual Box Scale (VBS) for pain administered while the patient is undergoing the abortion procedure.

Secondary Outcome Measures:
  • After the procedure the physician will estimate the patient’s pain using a VBS. The physician will also estimate the ease of the procedure using a different VBS.

Estimated Enrollment: 200
Study Start Date: May 2001
Estimated Study Completion Date: May 2006
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must meet the following inclusion criteria: after completion of a full history and physical exam each subject must be judged physically and mentally stable by the enrolling practitioner; subjects must be between 7 and 11 weeks pregnant and desiring termination. Gestation dating must be based on a reliable menstrual history consistent with a bimanual exam or ultrasound. All subjects must give informed consent after the study has been explained.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310921

Locations
United States, California
Kaiser Permanente, Department of OB/GYN
San Francisco, California, United States, 94115
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Seth Feigenbaum, M.D. Kaiser Permanente Medical Group, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310921     History of Changes
Other Study ID Numbers: CN-00SFeig-04-B
Study First Received: April 3, 2006
Last Updated: April 10, 2007
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 26, 2014