Evaluating ulipristal acetate and misoprostol for induced abortion through 63 days of pregnancy
| ISRCTN | ISRCTN35625202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35625202 |
| Secondary identifying numbers | 1043 |
- Submission date
- 12/08/2022
- Registration date
- 16/08/2022
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Abortion with mifepristone and misoprostol is safe, acceptable and effective, and it is recognized worldwide as the first-line treatment for outpatient first-trimester abortion. When mifepristone is not commercially available or difficult to access, misoprostol alone can be used instead, but it is not as effective and is associated with increased side effects because of the need to take more misoprostol. Evidence is required of medication used together with misoprostol that could offer an accessible alternative to the standard treatment. The antiprogestin activity of ulipristal is similar to that of mifepristone and suggests the possibility that together ulipristal and misoprostol could be a safe, acceptable and effective form of medication abortion. The purpose of this study is to identify a treatment schedule for ulipristal followed by misoprostol for induced abortion through 63 days of pregnancy that has minimal complications and is highly acceptable to users. We will evaluate two different doses of ulipristal with misoprostol to see if one works better and then will continue to evaluate the better one to learn more about it.
Who can participate?
Participants residing in Mexico City of at least 18 years old (or emancipated minors) seeking an abortion for a viable pregnancy that is 63 days or less.
What does the study involve?
The study involves swallowing one set of pills (ulipristal) in the clinic and remaining one hour afterwards to respond to questions about any side effects. Twenty-four hours later, participants will self-administer another set of pills (misoprostol) by holding them in their cheeks for 20-30 minutes and then swallowing any remaining bits. Participants will return to the clinic a week later to determine the status of the abortion. If any additional management is needed, the study clinician will provide that. All participants will respond to a series of questions about their experiences using the study medications and the acceptability of the regimen.
What are the possible benefits and risks of participating?
Participants benefit from getting an opportunity to use a new medication abortion method. Participants will also receive compensation for transportation to/from the clinic. There is no additional direct benefit for participating in the study, however, participants will contribute information that could help future abortion seekers access safe and effective abortion with new combinations of existing medications.
Possible risks are similar to those with standard medication abortion:
1. The method does not work to interrupt the pregnancy. In this case, the clinician can perform a uterine aspiration to complete the abortion.
2. The method interrupts the pregnancy but not completely. Depending on the participant's symptoms, they will be recommended different management options, including waiting more time, taking another dose of misoprostol or having a uterine aspiration.
3. Rarely, very excessive bleeding can result in blood transfusion.
4. Very few users have reported an allergic reaction to the study medications. In case of an allergic reaction after taking ulipristal, the participant will be cared for immediately at the clinical site.
5. Infection is a very rare complication of any abortion method. The study clinician will manage any signs and symptoms of infection with antibiotics and perform a uterine aspiration to complete the abortion.
Where is the study run from?
Participating sites in Mexico City (Mexico)
When is the study starting and how long is it expected to run for?
July 2019 to August 2023
Who is funding the study?
Options for Pregnancy Termination Innovation Initiative ('OPTions Initiative')
Who is the main contact?
Manuel Bousiéguez, mbousieguez@gynuity.org
Contact information
Scientific
Gynuity Health Projects
220 E 42nd Street, Suite 710
New York
10017
United States of America
| Phone | +1 212 448 1230 |
|---|---|
| mbousieguez@gynuity.org |
Public
Gynuity Health Projects
220 E 42nd Street, Suite 710
New York
10017
United States of America
| Phone | +1 212 448 1230 |
|---|---|
| idzuba@gynuity.org |
Study information
| Study design | Two-phase sequential intervention study: open-label randomized parallel study followed by one-arm open-label study with historical controls |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Adverse events, acceptability and efficacy of a combined regimen of ulipristal acetate and misoprostol for abortion through 63 days of gestation |
| Study hypothesis | We expect that: 1. The adverse events profile of ulipristal and misoprostol will not be inferior to the adverse event profile reported with misoprostol alone 2. Acceptability rates among study participants will be above 90% and similar to those observed with misoprostol alone regimens 3. Efficacy rates will not be inferior to those observed with misoprostol alone |
| Ethics approval(s) | 1. Approved 04/07/2022, Research Ethics Committee of the Secretariat of Health of Mexico City (Comité de ética en investigación de la Secretaría de Salud de la Ciudad de México, Avenida Insurgentes #423, Floor 14, Col. Nonoaico Tlatelolco, Del. Cuauhtémoc Ciudad de México, CP 06900; +52 55 51321200 Ext. 1360; ceinc.sedesa@gmail.com), ref: 101-100-041-22 2. Approved 26/06/2023, Research Ethics Committee of the Secretariat of Health of Mexico City (Comité de ética en investigación de la Secretaría de Salud de la Ciudad de México) |
| Condition | Induced abortion |
| Intervention | Phase 1 of the research will compare two medication regimens with ulipristal acetate and misoprostol: 60 mg UPA orally + 800 mcg misoprostol buccally versus 90 mg UPA orally + 800 mcg misoprostol buccally. Participants will be randomized to the study groups based on a computer-generated assignment. Phase 2 of the research will continue to evaluate the regimen that demonstrated the best outcomes in Phase 1. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | Ulipristal acetate, misoprostol |
| Primary outcome measure | Adverse events (complications) measured using self-reporting at any point prior to discharge from the study |
| Secondary outcome measures | Current secondary outcome measures as of 06/08/2024: 1. Side effects measured using self-reporting 1 hour after ulipristal administration and at the scheduled follow-up visit 7-10 later 2. Efficacy measured using a clinical assessment and ultrasound findings of abortion outcome at the scheduled follow-up visit 7-10 days later 3. Acceptability to participants of study medication measured using self-reporting at discharge from the study 4. Pain measured using a scale from 0-10 one hour after ulipristal administration and at the scheduled follow-up visit 7-10 days later Previous secondary outcome measures: 1. Side effects measured using self-reporting 1 hour after ulipristal administration and at the 1-week follow-up visit 2. Efficacy measured using a clinical assessment of pregnancy viability at the 1-week follow-up 3. Acceptability to participants of study medication measured using self-reporting at discharge from the study 4. Pain measured using a scale from 0-10 one hour after ulipristal administration and at the 1-week follow-up visit |
| Overall study start date | 01/07/2019 |
| Overall study end date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Phase 1: 66 participants; Phase 2: 100 participants |
| Total final enrolment | 166 |
| Participant inclusion criteria | 1. Pregnant with estimated gestational age ≤63 days by ultrasound and desiring an abortion 2. Body mass index (BMI) ≤32 kg/m² 3. Aged ≥18 years old or emancipated minor 4. With access to a telephone for follow-up communication 5. Resident of Mexico City 6. Able to provide informed consent |
| Participant exclusion criteria | 1. History of hepatic or renal disease 2. Confirmation or suspicion of ectopic pregnancy, gestational trophoblastic disease or undiagnosed adnexal mass 3. IUD in place 4. History of allergy to ulipristal or misoprostol (or other prostaglandins) 5. Unwilling to or with significant difficulty preventing return to clinic for follow up 6. Unable to provide informed consent |
| Recruitment start date | 31/08/2022 |
| Recruitment end date | 31/08/2023 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Del. Venustiano Carranza
Mexico City
15310
Mexico
Sponsor information
Research organisation
220 E 42nd Street
Suite 710
New York
10017
United States of America
| Phone | +1 212 448 1230 |
|---|---|
| pubinfo@gynuity.org | |
| Website | https://www.gynuity.org |
"ROR" |
https://ror.org/00swp5c87 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer-reviewed journal 2. Presentation at relevant conferences |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 23/01/2025 | 27/01/2025 | Yes | No |
Editorial Notes
27/01/2025: Publication reference added.
26/09/2024: A contact was removed.
25/09/2024: The intention to publish date was changed from 30/09/2024 to 30/11/2024.
06/08/2024: The following changes were made to the study record:
1. The overall study end date was changed from 31/08/2023 to 31/10/2023.
2. The intention to publish date was changed from 31/08/2024 to 30/09/2024.
3. Total final enrolment and pharmaceutical study type added.
4. The secondary outcome measures were updated.
09/08/2023: The following changes were made to the trial record:
1. The ethics approval (2) was added.
2. The recruitment end date was changed from 07/08/2023 to 31/08/2023.
3. The scientific contact was changed.
02/09/2022: The recruitment start date was changed from 15/09/2022 to 31/08/2022.
16/08/2022: Trial's existence confirmed by the Research Ethics Committee of the Secretariat of Health of Mexico City.
