Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg administered 1.5 hours before D&E.

Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.

Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability

Study Overview

• Status: Completed
• Conditions: Abortion, Induced
• Intervention / Treatment: Drug: Misoprostol 400 mcg 3 hours prior to procedure; Drug: Misoprostol 600 mcg 90 minutes prior to procedure

Detailed Description

The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10012
      • Planned Parenthood of New York City - Margaret Sanger Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 18 years of age and older
• Eligible for pregnancy termination at Planned Parenthood of NYC
• Able to give informed consent
• English speaking

Exclusion Criteria:

• Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
• Intrauterine fetal demise identified on pre-operative ultrasound
• Allergy to misoprostol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 400 mcg; receives 400 mcg of misoprostol 3 hours prior to the procedure	Drug: Misoprostol 400 mcg 3 hours prior to procedure; Misoprostol 400 mcg 3 hours prior to D&E procedure
Experimental: 600 mcg; receives 600 mcg of misoprostol 90 minutes prior to the procedure	Drug: Misoprostol 600 mcg 90 minutes prior to procedure; Misoprostol 600 mcg 90 minutes prior to D&E procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure time	Operative time defined as time from speculum in vagina to speculum out of vagina.	day of abortion procedure

Collaborators and Investigators

• Sponsor: Planned Parenthood of Greater New York
• Investigators: Principal Investigator: Gillian Dean, MD, MPH, Planned Parenthood of NYC

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: MISO