MedTrace Logo

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

NCT02279914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-04-26

No results posted yet for this study

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

Interventions

DRUG

Misoprostol 400 mcg 3 hours prior to procedure

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

DRUG

Misoprostol 600 mcg 90 minutes prior to procedure

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

Sponsors & Collaborators

  • Planned Parenthood of Greater New York

    lead OTHER

Principal Investigators

  • Gillian Dean, MD, MPH · Planned Parenthood of NYC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279914 on ClinicalTrials.gov