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NCT01636063 · ClinicalTrials.gov registry record · NA
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks
A NA study, sponsored by Boston University.
- Terminated
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT01636063 is a NA study that was terminated before completion, run by Boston University. The registered enrollment target is 42 participants.
The verdict
NCT01636063, a NA study, was terminated before completion, sponsored by Boston University.
- TERMINATED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
Surgical abortion in the late first trimester and early second trimester is usually performed with the aid of a cervical preparing agent, which helps to open up the uterine cervix for the procedure. Routine use of cervical preparants is recommended by several organizations during this period of pregnancy before surgical abortion, especially in younger women or those who have not delivered a baby, because their cervices may be more difficult to dilate without a preparant. The standard medication used for cervical preparation is misoprostol. Unfortunately, misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who use it. Another medication called mifepristone has been shown to dilate the cervix better than misoprostol in the first trimester, but little information exists about using mifepristone in the late first trimester and early second trimester. The investigators plan to perform a prospective, double-blind, randomized trial to evaluate if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be recruited. Half will receive mifepristone and the other half misoprostol. The investigators will measure the amount of cervical dilation achieved right before a surgical abortion to determine if mifepristone is significantly different than misoprostol as a cervical preparant at this stage of pregnancy. The investigators expect that mifepristone will work better than misoprostol for this purpose. The investigators hope to generate information about mifepristone so that women and their health care providers can know more about mifepristone as an option for cervical preparation before surgical abortion.
Interventions
- DRUG Mifepristone
- DRUG Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01636063
The ClinicalTrials.gov registry entry for NCT01636063 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mifepristone is the first listed.
NCT01636063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01636063 about?
NCT01636063 is a clinical study titled "Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks". Surgical abortion in the late first trimester and early second trimester is usually performed with the aid of a cervical preparing agent, which helps to open up the uterine cervix for the procedure. Routine use of cervical preparants is recommended by several organizations during this period of preg...
What is the current status of trial NCT01636063?
This trial is currently terminated. It is a NA study. The enrollment target is 42 participants. The study started on 2012-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01636063?
The interventions under investigation include: Mifepristone (DRUG), Misoprostol (DRUG).
Who is sponsoring clinical trial NCT01636063?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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