Labor InductionNCT01927822
Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol
An observational study of Labor Induction, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol. Read more about this study
- Who is it for?
- Ages 13 to 50 years, women only
- Conditions the study is for
- Labor Induction
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: This is a single-center, retrospective chart review study. All female patients who were admitted for medical termination of second-trimester pregnancy from January 2008 to May 2013, at the Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital were recruited.
Who may be able to join
- 1.All female patients who were admitted for medical termination of second-trimester pregnancy
Who cannot join
- 1. Patients who are allergy to Cytotec.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.
Read the detailed description
Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.
- Conditions
- Labor Induction
- Keywords
- termination of pregnancy, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy | Women who underwent termination of pregnancy at second trimester due to a variety of causes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful termination rate by Cytotec.
Measured: 1 week
Secondary outcomes (1)
Factors affecting abortion interval by cytotec.
To identify the factors affecting termination interval Cox regression model.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
- Investigators
- Sheng-Mou Hsiao, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927822
- Sponsor's protocol ID
- 102096-F
- Status last verified
- Jul 2015
- First submitted
- 18 Aug 2013
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol
- ClinicalTrials.gov ID
- NCT01927822
- Acronym / sponsor ID
- 102096-F
- Conditions
- Labor Induction
- Keywords
- termination of pregnancy, abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.
Detailed description
Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy | – | –Women who underwent termination of pregnancy at second trimester due to a variety of causes |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This is a single-center, retrospective chart review study. All female patients who were admitted for medical termination of second-trimester pregnancy from January 2008 to May 2013, at the Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital were recruited.
Key inclusion criteria (1 listed)
- 1.All female patients who were admitted for medical termination of second-trimester pregnancy
Key exclusion criteria (1 listed)
- 1. Patients who are allergy to Cytotec.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful termination rate by Cytotec.
Time frame: 1 week
1 secondary outcome
Factors affecting abortion interval by cytotec.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Mou Hsiao, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Induction, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful termination rate by Cytotec. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.