Abortion in Second TrimesterPhase 4NCT03346629
Outpatient Service for Mid-trimester Termination of Pregnancy
A Phase 4 study testing Mifepristone + Misoprostol in people with Abortion in Second Trimester, run by Gynuity Health Projects at 3 sites in Nepal.
Trial summary
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in Second Trimester
- What is being tested?
- Mifepristone + Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesNepal
- Study dates
- 1 Dec 2017to 31 Dec 2018
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have an ongoing pregnancy of 13-18 weeks gestation
- Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
- Has access to a phone where she can be reached at the 2-week follow-up
- Be willing to follow study procedures
Who cannot join
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- More than one prior cesarean delivery
- Living more than 2 hours away from the hospital
Trial locations and contacts
3 sites in 1 country.
Nepal3 sites
KIST Medical College, Teaching Hospital
Imadol, Lalitpur
Kathmandu Medical College
Kathmandu
Kathmandu Model Hospital
Kathmandu
About this study
Official title: Evaluating the Safety, Acceptability and Feasibility of an Outpatient "Day Procedure" Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.
- Conditions
- Abortion in Second Trimester
- Being tested
- Mifepristone + Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone + MisoprostolDrug
A single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs.
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone + Misoprostol | Experimental | Intervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3) Receives: Drug: Mifepristone + Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful medical abortion
Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction
Measured: 0 - 48 hours after first dose of mifepristone
Secondary outcomes (7)
Induction-to-abortion interval
Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta
Measured: 0 - 48 hours after first misoprostol dose
Total dose of misoprostol
Average number of doses of misoprostol
Measured: 0 - 48 hours after first misoprostol dose
Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
Measured: 2 weeks after initial visit
Tasks performed by certified staff
Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge)
Measured: 0 - 72 hours after receipt of mifepristone
Hospital admission time
Average total hospital admission time
Measured: Within 0 - 48 hours after the second dose of misoprostol
Side Effects
Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale)
Measured: 0 - 48 hours after first dose of misoprostol
Initiation-to-abortion interval
Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta
Measured: 0 - 72 hours after receipt of mifepristone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion in Second TrimesterStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- CREHPA, Kathmandu Medical College and Teaching Hospital, Kathmandu Model Hospital, KIST Medical College
- Responsible party
- Sponsor
- Investigators
- Jennifer Blum, MPH, Principal investigator, Gynuity Health ProjectsMonica Dragoman, MD, MPH, Principal investigator, Gynuity Health ProjectsChanda Karki, MD, Principal investigator, Kathmandu Medical CollegeDina Abbas, MPH, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsAnand Tamang, MPhil, Principal investigator, CREHPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346629
- Sponsor's protocol ID
- 1039
- Status last verified
- Apr 2019
- First submitted
- 15 Nov 2017
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety, Acceptability and Feasibility of an Outpatient "Day Procedure" Service Documenting the Roles of Health Workers in the Provision of Medical Abortion at 13-18 Weeks Gestation
- ClinicalTrials.gov ID
- NCT03346629
- Acronym / sponsor ID
- 1039
- Conditions
- Abortion in Second Trimester
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- CREHPA, Kathmandu Medical College and Teaching Hospital, Kathmandu Model Hospital, KIST Medical College
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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 seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mifepristone + Misoprostol | Experimental | Drug: Mifepristone + MisoprostolIntervention: 200mg mifepristone followed 24-48 h later with 400mcg misoprostol (repeat Q3) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Have an ongoing pregnancy of 13-18 weeks gestation
- Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman)
- Has access to a phone where she can be reached at the 2-week follow-up
- Be willing to follow study procedures
Key exclusion criteria (4 listed)
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- More than one prior cesarean delivery
- Living more than 2 hours away from the hospital
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 |
|---|---|---|
| Mifepristone + MisoprostolA single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs. | Drug | Mifepristone + Misoprostol |
Primary outcome
Successful medical abortion
Time frame: 0 - 48 hours after first dose of mifepristone
Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction
7 secondary outcomes
Induction-to-abortion interval
Time frame: 0 - 48 hours after first misoprostol dose
Total dose of misoprostol
Time frame: 0 - 48 hours after first misoprostol dose
Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
Time frame: 2 weeks after initial visit
Tasks performed by certified staff
Time frame: 0 - 72 hours after receipt of mifepristone
Hospital admission time
Time frame: Within 0 - 48 hours after the second dose of misoprostol
Side Effects
Time frame: 0 - 48 hours after first dose of misoprostol
Initiation-to-abortion interval
Time frame: 0 - 72 hours after receipt of mifepristone
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 26 Apr 2019.
Related trials for Abortion in Second Trimester
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
Not yet recruitingObservational study
Misoprostol in Missed Abortion
Abortion; Attempted
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.
Jennifer Blum, MPH principal investigator
Gynuity Health Projects
Monica Dragoman, MD, MPH principal investigator
Gynuity Health Projects
Chanda Karki, MD principal investigator
Kathmandu Medical College
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone + Misoprostol in people with Abortion in Second Trimester, run by Gynuity Health Projects at 3 sites in Nepal.
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 4 inclusion and 4 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nepal. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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 medical abortion (time frame: 0 - 48 hours after first dose of mifepristone). 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 26 Apr 2019.