CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Misoprostol +3 moredrug
Likely dose
Misoprostol 400 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01862991
NCT01862991N/ACompleted

Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services

Stanford University·interventional·Posted May 27, 2013·Updated Feb 14, 2024

In Brief

A clinical study evaluating Hygroscopic cervical dilators, Misoprostol, and 2 other interventions for Legally Induced Abortion Without Mention of Complication. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 27, 2013
Enrollment StartJul 1, 2013
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.1 years ago

Interventions

Hygroscopic cervical dilatorsother

Dilapan-S osmotic cervical dilators inserted through the internal os.

Misoprostoldrug

400 mcg buccal misoprostol 90 pre-op

Intra-amniotic digoxindrug

1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation

Mifepristonedrug

200 mcg Mifepristone orally