Abortion in Second TrimesterPhase 4NCT05046041
Assessing Outpatient 'Day Procedure' for Second-trimester Medical Abortion at Two Public Sector Hospitals in Nepal
A Phase 4 study testing Mifepristone + Misoprostol in people with Abortion in Second Trimester, run by Gynuity Health Projects at 2 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 in two public sector facilities. 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
- 120 participants
- Where
- 2 sitesNepal
- Study dates
- 25 Nov 2020to 31 Aug 2021
- 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 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)
- Have access to a phone where she can be reached at the 2-week follow up or willing to return to the clinic for an in-person interview with the research assistant
- 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
2 sites in 1 country.
About this study
Official title: A Study of Acceptability and Feasibility of an Outpatient "Day Procedure" for Medical Abortion at 13-18 Weeks Gestation in Two Public Sector Hospitals in Nepal
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient "day procedure" for medical abortion at 13-18 weeks gestation in two public sector facilities. It also seeks to document the roles of health workers in providing services related to later abortion care and to document the costs of this day procedure to the health system.
- 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 200 mg mifepristone (one tablet) 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 (buccal) every three hours until the abortion is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone + Misoprostol | Experimental | 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.
Proportion of participants with method success on the same day as misoprostol initiation.
Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day
Measured: 0 - 48 hours after first dose of mifepristone
Secondary outcomes (9)
Average induction-to-abortion interval
Time interval from administration of the first misoprostol dose until expulsion of both fetus and placenta
Measured: 0 - 48 hours after first misoprostol dose
Average number of total doses of misoprostol
Total misoprostol doses administered from induction to delivery of placenta.
Measured: 0 - 48 hours after first misoprostol dose
Frequency of adverse events
Adverse events include extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, or prolonged hospitalization, any complications (immediate and delayed)
Measured: 0-2 weeks after initial visit
Description of tasks performed by different cadres of study staff
Tasks evaluated include counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge
Measured: 0 - 72 hours after receipt of mifepristone
Average total hospital admission time
Total hospital admission time, including: 1) total admission time during treatment with misoprostol and abortion recovery 2) Additional hospital time required for the evaluation and management of complications
Measured: Within 0 - 48 hours after the second dose of misoprostol
Average pain scores
Severity incidence based on a 0-10 point pain scale
Measured: 0 - 48 hours after first dose of misoprostol
Frequency of individual side effects experienced by participants
Side effects evaluated include diarrhea, nausea, vomiting, fever, chills
Measured: 0 - 48 hours after first dose of misoprostol
Proportion of reported complications
Participants who returned to a health facility for evaluation and management of complications within 2 weeks of taking mifepristone
Measured: 0-2 weeks after initial visit
Proportion of satisfied participants
Participants who report high satisfaction with service
Measured: 2 weeks after initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start25 Nov 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- KIST Medical College and Teaching Hospital, Center for Research on Environment, Health and Population Activities, Bharatpur Eye Hospital, Lumbini Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Inga Platais, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, Principal investigator, Gynuity Health ProjectsAnand Tamang, Principal investigator, CREHPASajan K.C, MD, Principal investigator, Bharatpur Eye HospitalShreedhar Acharya, MD, Principal investigator, Lumbini Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046041
- Sponsor's protocol ID
- 1051
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Acceptability and Feasibility of an Outpatient "Day Procedure" for Medical Abortion at 13-18 Weeks Gestation in Two Public Sector Hospitals in Nepal
- ClinicalTrials.gov ID
- NCT05046041
- Acronym / sponsor ID
- 1051
- Conditions
- Abortion in Second Trimester
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- KIST Medical College and Teaching Hospital, Center for Research on Environment, Health and Population Activities, Bharatpur Eye Hospital, Lumbini Provincial Hospital
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 16 Sep 2021 (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 in two public sector facilities. It also seeks to document the roles of health workers in providing services related to later abortion care and to document the costs of this day procedure to the health system.
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 + Misoprostol200mg 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 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)
- Have access to a phone where she can be reached at the 2-week follow up or willing to return to the clinic for an in-person interview with the research assistant
- 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 200 mg mifepristone (one tablet) 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 (buccal) every three hours until the abortion is achieved. | Drug | Mifepristone + Misoprostol |
Primary outcome
Proportion of participants with method success on the same day as misoprostol initiation.
Time frame: 0 - 48 hours after first dose of mifepristone
Success is defined as expelling fetus and placenta without surgical intervention and return home on the same day
9 secondary outcomes
Average induction-to-abortion interval
Time frame: 0 - 48 hours after first misoprostol dose
Average number of total doses of misoprostol
Time frame: 0 - 48 hours after first misoprostol dose
Frequency of adverse events
Time frame: 0-2 weeks after initial visit
Description of tasks performed by different cadres of study staff
Time frame: 0 - 72 hours after receipt of mifepristone
Average total hospital admission time
Time frame: Within 0 - 48 hours after the second dose of misoprostol
Average pain scores
Time frame: 0 - 48 hours after first dose of misoprostol
Frequency of individual side effects experienced by participants
Time frame: 0 - 48 hours after first dose of misoprostol
Proportion of reported complications
Time frame: 0-2 weeks after initial visit
Proportion of satisfied participants
Time frame: 2 weeks after initial visit
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 16 Sep 2021.
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.
Inga Platais principal investigator
Gynuity Health Projects
Beverly Winikoff principal investigator
Gynuity Health Projects
Anand Tamang principal investigator
CREHPA
2 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 2 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 16 Sep 2021. 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 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?
Proportion of participants with method success on the same day as misoprostol initiation. (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 16 Sep 2021.