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

NCT02279914 | Completed

• 1 other identifier: Miso
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abortion, Induced

Outcome Measures

Primary Outcomes (1)

• procedure time

  Operative time defined as time from speculum in vagina to speculum out of vagina.

  day of abortion procedure

Study Arms (2)

400 mcg

EXPERIMENTAL

receives 400 mcg of misoprostol 3 hours prior to the procedure

Drug: Misoprostol 400 mcg 3 hours prior to procedure

600 mcg

EXPERIMENTAL

receives 600 mcg of misoprostol 90 minutes prior to the procedure

Drug: Misoprostol 600 mcg 90 minutes prior to procedure

Interventions

Misoprostol 400 mcg 3 hours prior to procedure DRUG

Misoprostol 400 mcg 3 hours prior to D\&E procedure

400 mcg

Misoprostol 600 mcg 90 minutes prior to procedure DRUG

Misoprostol 600 mcg 90 minutes prior to D\&E procedure

600 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Planned Parenthood of Greater New York: lead

Study Sites (1)

Planned Parenthood of New York City - Margaret Sanger Center

New York, New York, 10012, United States

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Gillian Dean, MD, MPH

  Planned Parenthood of NYC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

US (1)