Second Trimester Labor InductionPhase 1NCT00592215
Second Trimester Labor Induction
A Phase 1 study testing Experimental (mifepristone and misoprostol) in people with Second Trimester Labor Induction, run by Johns Hopkins University at 2 sites in United States.
Trial summary
A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Trimester Labor Induction
- What is being tested?
- Experimental (mifepristone and misoprostol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Oct 2010
- Phase
- Phase 1
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking women
- 18 years of age and above
- Voluntarily choose to undergo pregnancy termination via labor induction
- An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
- Able to provide written consent
Who cannot join
- Premature rupture of membranes
- Preterm labor
- Intrauterine fetal demise
- Chronic systemic corticosteroid use or adrenal disease
- Hypersensitivity to prostaglandins
- Cardiovascular disease such as angina, valvular disease, arrhythmia, cardiac failure
Show all 9Show fewer
- Known coagulopathy or treatment with anticoagulants
- Prior caesarean delivery or myomectomy
- Placenta previa
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21205
About this study
Official title: A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion
A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.
The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.
- Conditions
- Second Trimester Labor Induction
- Being tested
- Experimental (mifepristone and misoprostol)
- Keywords
- Second trimester labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (mifepristone and misoprostol)Drug
Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Mifepristone followed by labor induction with misoprostol after 6-8 hours Receives: Drug: Experimental (mifepristone and misoprostol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abortion rate
Measured: 8 hours after misoprostol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Trimester Labor InductionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Rameet Singh, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592215
- Sponsor's protocol ID
- NA_00010268
- Other IDs
- 2007-663
- Status last verified
- Dec 2017
- First submitted
- 31 Dec 2007
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Mifepristone Followed by Misoprostol in Women Undergoing Second Trimester Abortion
- ClinicalTrials.gov ID
- NCT00592215
- Acronym / sponsor ID
- NA_00010268
- Conditions
- Second Trimester Labor Induction
- Keywords
- Second trimester labor induction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- Mar 2008 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Jan 2008 (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.
A superior second trimester medical abortion regimen has not been identified. Studies suggest that a regimen of mifepristone and misoprostol given 36 to 48 hours apart has the shortest median induction-to-abortion interval, highest 24-hour abortion rate, and low rates of adverse events. Narrowing the interval between the two medications without clinically reducing effectiveness may increase access and acceptability for patients and reduce costs. Data from studies on first trimester abortions suggest that the 6 to 8 hour interval between mifepristone and misoprostol is as efficacious as the 36 to 48 hour interval. There are no studies on shorter intervals with same day administration between mifepristone and misoprostol in second trimester abortions.
The primary objective is to assess the efficacy of the combined mifepristone/misoprostol regimen for abortions between 17 0/7 and 23 6/7 weeks' gestation using an interval of 6 to 8 hours between the two medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Experimental (mifepristone and misoprostol)Mifepristone followed by labor induction with misoprostol after 6-8 hours |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English-speaking women
- 18 years of age and above
- Voluntarily choose to undergo pregnancy termination via labor induction
- An ultrasound-confirmed singleton intrauterine pregnancy between 17 0/7 and 23 6/7 weeks gestation
- Able to provide written consent
Key exclusion criteria (9 listed)
- Premature rupture of membranes
- Preterm labor
- Intrauterine fetal demise
- Chronic systemic corticosteroid use or adrenal disease
- Hypersensitivity to prostaglandins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental (mifepristone and misoprostol)Mifepristone 200mg followed by labor induction with misoprostol after 6-8 hours | Drug | A |
Primary outcome
Abortion rate
Time frame: 8 hours after misoprostol administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
Related trials for Second Trimester Labor Induction
RecruitingPhase 1
Pharmacokinetics and Placental Transfer of Caffeine
Preterm Labor With Preterm Delivery, Premature Birth
Recruiting
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
Pregnancy Related, Remote Monitoring
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.
Rameet Singh, MD, MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental (mifepristone and misoprostol) in people with Second Trimester Labor Induction, run by Johns Hopkins University at 2 sites in United States.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Abortion rate (time frame: 8 hours after misoprostol administration). 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 8 Dec 2017.