Medical Abortion, Complete or Unspecified, Without ComplicationRAPMNCT04160221
Second Trimester Medical Abortion
A study testing 12 hours interval and 24 hours interval in people with Medical Abortion, Complete or Unspecified, Without Complication, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical Abortion, Complete or Unspecified, Without Complication
- What is being tested?
- 12 hours interval and 24 hours interval
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2019to 1 Oct 2024
- Phase
- Interventional
- 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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 years and older about to undergo medical second trimester abortion
- 12+0 to 28+0 weeks of gestation
- Singleton intrauterine pregnancy
- Able to sign informed consent
Who cannot join
- Inability to give informed consent
- Allergy to any of the drugs used in the study
- Genital bleeding of unknown etiology; cancer of the breast, cervix, uterus, or ovaries; hepatic disease (current or history of)
- Multiple gestation
- Rupture of membranes
- Taken a CYP3A4 inhibitor within 5 elimination half-lives of the drug from the procedure
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- Pre-dosing abnormal liver function tests
- Patients at increased risk of hepatitis based on a history of any of the following:
- Any history of underlying liver disorder, including hepatitis
- A family history of hepatitis or currently living with a person 441 who has been given a diagnosis of hepatitis
- A history of or currently working as a sex worker
- A history of or currently using IV drugs
- A self-reported history of alcoholic dependency or abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second Trimester Medical Abortion- New Strategies
The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, have revealed shorter total abortion time with shorter intervals. In this study we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals
Read the detailed description
Women are looking for termination of pregnancies in the second trimester, after 12 weeks of gestation for social and medical reasons, as well as due to intrauterine fetal demise. Both surgical and medical methods can be used, depending on the patients' preference, providers skills, availability of drugs and instruments and more. Methods of medical abortion can be performed with the use of prostaglandin analogues, mifepristone, oxytocin, foley catheter and osmotic dilators. Misoprostol, a prostaglandin analogue (PGE1), is currently recommended over other agents due to its efficacy, low cost and ease of use. Misoprostol can be used alone or in combination with other agents. The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Current guidelines recommend the use of Mifepristone 200 mg orally, followed by Misoprostol 400 mcg every 3-4, hours 24-48 later until expulsion of the fetus. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, ≤12, 12-24 and >24 hours, have revealed shorter total abortion time (time from Mifepristone to fetal expulsion) with the shorter intervals. Thus, strict adherence to current guidelines may unnecessarily prolong the abortion procedure.
Objective Prompted by the need to explore more beneficial methods and regimes for second trimester medical abortion, we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals
Material and Methods Women eligible for second trimester medical abortion will be approached to enroll in the study at the clinic or emergency room when they arrive to schedule medical abortion. A research staff member will obtain informed consent. The patient will undergo a blood test including blood type, complete blood count and chemistry. Basic demographic information will be collected. A complete history and physical assessment will be performed. If an ultrasound report is not available to confirm gestational age dating, ultrasound will be performed to determine gestational age. A baseline cervical exam will be done at this visit to assess cervical consistency. Patients will be randomized into one of two groups according to a computer-generated random allocation sequence. Sequentially numbered sealed opaque envelopes will be used to provide allocation.
- Patients allocated to group 1 will receive 200 mg Mifepristone orally, followed by Misoprostol 400 mcg vaginally 12 hours later and subsequently 400 mcg orally every three hours until fetal expulsion to a maximum of 5 doses.
- Patients allocated to group 2 will receive 200 mg Mifepristone orally, followed by Misoprostol 400 mcg vaginally 24 hours later and subsequently 400 mcg orally every three hours until fetal expulsion to a maximum of 5 doses.
Patients will be discharged home after receiving Mifepristone, and hospitalized upon arrival for the Misoprostol administration.
If the abortion is not complete after five doses, the woman may be allowed to rest for 12 hours before starting the cycle again.
All participants will be contacted by phone as well as a chart review conducted to assess for delayed complications. During this follow up time, they will be asked to notify the research team if they should develop fatigue, malaise, abdominal pain, or jaundice. If these symptoms occur, a workup for liver injury would be performed. Patients will be asked to obtain repeat liver function tests within two weeks post-procedure to compare to their baseline hepatic panel.
- Being tested
- 12 hours interval, 24 hours interval
- Keywords
- Medical Abortion, Mifepristone, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 hours intervalOther
Time interval between treatments
24 hours intervalOther
Time interval between treatments
| Study group | Role | What they receive |
|---|---|---|
| 12 hours interval | Active comparator | Mifepristone followed by Misoprostol treatment Receives: Other: 12 hours interval |
| 24 hours interval | Active comparator | Mifepristone followed by Misoprostol treatment Receives: Other: 24 hours interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction-abortion time
Total induction to complete abortion ( estimated by hours)
Measured: Through completion of abortion, an estimated period of up to 3 days
Secondary outcomes (3)
Fever
Fever measure above 38 degrees
Measured: From the beginning until completion of abortion,estimated up to two weeks
Excessive blood loss
Excessive blood loss estimated by the medical team ( remnants of blood on pad, active bleeding estimated to be equal to menstruation, heavier bleeding including blood clots, blood loss leading to hemodynamically instability including tachycardia and/or reduced blood pressure)
Measured: From the beginning until completion of abortion, estimated up to two weeks
Any emergency department visit
Emergency department visit during the abortion or reported on follow up
Measured: From the beginning until completion of abortion, estimated up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Medical Abortion, Complete or Unspecified, Without ComplicationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Aya A Mohr-Sasson, M.D, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160221
- Sponsor's protocol ID
- 6416-19
- Acronym
- RAPM
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2019
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006714. doi: 10.1002/14651858.CD006714.pub2.
PubMed 18254113ACOG Practice Bulletin No. 135: Second-trimester abortion. Obstet Gynecol. 2013 Jun;121(6):1394-1406. doi: 10.1097/01.AOG.0000431056.79334.cc. No abstract available.
PubMed 23812485Borgatta L, Kapp N; Society of Family Planning. Clinical guidelines. Labor induction abortion in the second trimester. Contraception. 2011 Jul;84(1):4-18. doi: 10.1016/j.contraception.2011.02.005. Epub 2011 Mar 30.
PubMed 21664506Costescu D, Guilbert E. No. 360-Induced Abortion: Surgical Abortion and Second Trimester Medical Methods. J Obstet Gynaecol Can. 2018 Jun;40(6):750-783. doi: 10.1016/j.jogc.2017.12.010.
PubMed 29861084Li HWR, Gemzell-Danielsson K. Mechanisms of action of emergency contraception pills. Eur J Contracept Reprod Health Care. 2019 Feb;24(1):11-12. doi: 10.1080/13625187.2018.1555663. Epub 2019 Jan 21. No abstract available.
PubMed 30664367Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.
PubMed 22296076Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
PubMed 14667994Meyer R, Toussia-Cohen S, Shats M, Segal O, Mohr-Sasson A, Peretz-Bookstein S, Amitai-Komem D, Sindel O, Levin G, Mashiach R, Blumenthal PD. 24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jul 1;144(1):60-67. doi: 10.1097/AOG.0000000000005535. Epub 2024 May 23.
PubMed 38781593
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Trimester Medical Abortion- New Strategies
- ClinicalTrials.gov ID
- NCT04160221
- Acronym / sponsor ID
- RAPM / 6416-19
- Keywords
- Medical Abortion, Mifepristone, Misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Stanford University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Nov 2019 (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.
The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, have revealed shorter total abortion time with shorter intervals. In this study we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals
Detailed description
Women are looking for termination of pregnancies in the second trimester, after 12 weeks of gestation for social and medical reasons, as well as due to intrauterine fetal demise. Both surgical and medical methods can be used, depending on the patients' preference, providers skills, availability of drugs and instruments and more. Methods of medical abortion can be performed with the use of prostaglandin analogues, mifepristone, oxytocin, foley catheter and osmotic dilators. Misoprostol, a prostaglandin analogue (PGE1), is currently recommended over other agents due to its efficacy, low cost and ease of use. Misoprostol can be used alone or in combination with other agents. The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Current guidelines recommend the use of Mifepristone 200 mg orally, followed by Misoprostol 400 mcg every 3-4, hours 24-48 later until expulsion of the fetus. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, ≤12, 12-24 and >24 hours, have revealed shorter total abortion time (time from Mifepristone to fetal expulsion) with the shorter intervals. Thus, strict adherence to current guidelines may unnecessarily prolong the abortion procedure.
Objective Prompted by the need to explore more beneficial methods and regimes for second trimester medical abortion, we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals
Material and Methods Women eligible for second trimester medical abortion will be approached to enroll in the study at the clinic or emergency room when they arrive to schedule medical abortion. A research staff member will obtain informed consent. The patient will undergo a blood test including blood type, complete blood count and chemistry. Basic demographic information will be collected. A complete history and physical assessment will be performed. If an ultrasound report is not available to confirm gestational age dating, ultrasound will be performed to determine gestational age. A baseline cervical exam will be done at this visit to assess cervical consistency. Patients will be randomized into one of two groups according to a computer-generated random allocation sequence. Sequentially numbered sealed opaque envelopes will be used to provide allocation.
- Patients allocated to group 1 will receive 200 mg Mifepristone orally, followed by Misoprostol 400 mcg vaginally 12 hours later and subsequently 400 mcg orally every three hours until fetal expulsion to a maximum of 5 doses.
- Patients allocated to group 2 will receive 200 mg Mifepristone orally, followed by Misoprostol 400 mcg vaginally 24 hours later and subsequently 400 mcg orally every three hours until fetal expulsion to a maximum of 5 doses.
Patients will be discharged home after receiving Mifepristone, and hospitalized upon arrival for the Misoprostol administration.
If the abortion is not complete after five doses, the woman may be allowed to rest for 12 hours before starting the cycle again.
All participants will be contacted by phone as well as a chart review conducted to assess for delayed complications. During this follow up time, they will be asked to notify the research team if they should develop fatigue, malaise, abdominal pain, or jaundice. If these symptoms occur, a workup for liver injury would be performed. Patients will be asked to obtain repeat liver function tests within two weeks post-procedure to compare to their baseline hepatic panel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 hours interval | Active comparator | Other: 12 hours intervalMifepristone followed by Misoprostol treatment |
| 24 hours interval | Active comparator | Other: 24 hours intervalMifepristone followed by Misoprostol treatment |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18 years and older about to undergo medical second trimester abortion
- 12+0 to 28+0 weeks of gestation
- Singleton intrauterine pregnancy
- Able to sign informed consent
Key exclusion criteria (13 listed)
- Inability to give informed consent
- Allergy to any of the drugs used in the study
- Genital bleeding of unknown etiology; cancer of the breast, cervix, uterus, or ovaries; hepatic disease (current or history of)
- Multiple gestation
- Rupture of membranes
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 |
|---|---|---|
| 12 hours intervalTime interval between treatments | Other | 12 hours interval |
| 24 hours intervalTime interval between treatments | Other | 24 hours interval |
Primary outcome
Induction-abortion time
Time frame: Through completion of abortion, an estimated period of up to 3 days
Total induction to complete abortion ( estimated by hours)
3 secondary outcomes
Fever
Time frame: From the beginning until completion of abortion,estimated up to two weeks
Excessive blood loss
Time frame: From the beginning until completion of abortion, estimated up to two weeks
Any emergency department visit
Time frame: From the beginning until completion of abortion, estimated up to two weeks
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 14 Nov 2024.
- Results publication: PubMed 18254113Lohr PA, Hayes JL, Gemzell-Danielsson K. Surgical versus medical methods for second trimester induced abortion. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006714. doi: 10.1002/14651858.CD006714.pub2.
- Results publication: PubMed 23812485ACOG Practice Bulletin No. 135: Second-trimester abortion. Obstet Gynecol. 2013 Jun;121(6):1394-1406. doi: 10.1097/01.AOG.0000431056.79334.cc. No abstract available.
- Results publication: PubMed 21664506Borgatta L, Kapp N; Society of Family Planning. Clinical guidelines. Labor induction abortion in the second trimester. Contraception. 2011 Jul;84(1):4-18. doi: 10.1016/j.contraception.2011.02.005. Epub 2011 Mar 30.
- Results publication: PubMed 29861084Costescu D, Guilbert E. No. 360-Induced Abortion: Surgical Abortion and Second Trimester Medical Methods. J Obstet Gynaecol Can. 2018 Jun;40(6):750-783. doi: 10.1016/j.jogc.2017.12.010.
- Results publication: PubMed 30664367Li HWR, Gemzell-Danielsson K. Mechanisms of action of emergency contraception pills. Eur J Contracept Reprod Health Care. 2019 Feb;24(1):11-12. doi: 10.1080/13625187.2018.1555663. Epub 2019 Jan 21. No abstract available.
- Results publication: PubMed 22296076Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.
- Results publication: PubMed 14667994Blithe DL, Nieman LK, Blye RP, Stratton P, Passaro M. Development of the selective progesterone receptor modulator CDB-2914 for clinical indications. Steroids. 2003 Nov;68(10-13):1013-7. doi: 10.1016/s0039-128x(03)00118-1.
- Derived from this study: PubMed 38781593Meyer R, Toussia-Cohen S, Shats M, Segal O, Mohr-Sasson A, Peretz-Bookstein S, Amitai-Komem D, Sindel O, Levin G, Mashiach R, Blumenthal PD. 24-Hour Compared With 12-Hour Mifepristone-Misoprostol Interval for Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2024 Jul 1;144(1):60-67. doi: 10.1097/AOG.0000000000005535. Epub 2024 May 23.
- Individual participant dataSharing planned: Undecided
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.
Aya A Mohr-Sasson, M.D principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 hours interval and 24 hours interval in people with Medical Abortion, Complete or Unspecified, Without Complication, run by Sheba Medical Center at 1 site in Israel.
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 13 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 14 Nov 2024. 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 Israel. 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?
Induction-abortion time (time frame: Through completion of abortion, an estimated period of up to 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160221, which also lists 8 linked publications.
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 14 Nov 2024.