Abortion Induced ComplicatedPhase 4RPOCNCT04685694
Management of RPOC After Induced Abortion
A Phase 4 study testing Misoprostol in people with Abortion Induced Complicated, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Induced Complicated
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 31 Jan 2022
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 < age < 45 year old
- Thick irregular endometrium >12 mm on trans-vaginal ultrasound
Who cannot join
- Endometritis
- Cervical opening > 1 cm
- Uterine abnormalities
- Contraindication to Misoprostol treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion
Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion
Read the detailed description
An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.
- Conditions
- Abortion Induced Complicated
- Being tested
- Misoprostol
- Keywords
- RPOC, induced abortion, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
sl 800 mcg misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Expectant | No intervention | No medication is assigned. |
| Medical | Experimental | SL 800 mcg Misoprostol Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
RPOC rate
RPOC rate in repeat ultrasound scan performed 5 weeks after randomization
Measured: 2 months
Secondary outcomes (2)
Adhesions
According to our study protocol all women with persistent products of conception diagnosed on repeated ultrasound examination undergo hysteroscopy. During hysteroscopy, assessment of the uterine cavity including intrauterine adhesion formation will be performed. Intrauterine adhesions will be classified according to the American Society for Reproductive Medicine (ASRM), based on the extent of cavity involvement (<1/3; 1/3 to 2/3, >2/3) and the type of adhesion seen (filmy, filmy and dense, dense).
Measured: 2 months
Bleeding
Bleeding pattern will be assessed via questionnaire upon recruitment and follow up visits. Bleeding will be characterized by its pattern (regular, intermenstrual) and quantity (normal, hypomenorrhoea, menorrhagia).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abortion Induced ComplicatedStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Yossi Tzur, MD, Study director, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685694
- Sponsor's protocol ID
- 0444-19-TLV
- Acronym
- RPOC
- Status last verified
- May 2022
- First submitted
- 1 Oct 2020
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: on line sharing via secured system
Publications
Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.
PubMed 16707509Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. doi: 10.1093/humrep/deh049.
PubMed 14747165Ashwal E, Melamed N, Hiersch L, Wiznitzer A, Yogev Y, Peled Y. The incidence and risk factors for retained placenta after vaginal delivery - a single center experience. J Matern Fetal Neonatal Med. 2014 Dec;27(18):1897-900. doi: 10.3109/14767058.2014.883374. Epub 2014 Feb 4.
PubMed 24417417Anteby M, Many A, Ashwal E, Yogev Y, Shinar S. Risk factors and complications of manual placental removal after vaginal delivery - how common are additional invasive procedures? J Matern Fetal Neonatal Med. 2019 Feb;32(3):384-388. doi: 10.1080/14767058.2017.1379071. Epub 2017 Sep 19.
PubMed 28891361Tzur Y, Berkovitz-Shperling R, Goitein Inbar T, Bar-On S, Gil Y, Levin I, Cohen A. Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study. Am J Obstet Gynecol. 2022 Oct;227(4):599.e1-599.e9. doi: 10.1016/j.ajog.2022.06.025. Epub 2022 Jun 23.
PubMed 35752301
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion
- ClinicalTrials.gov ID
- NCT04685694
- Acronym / sponsor ID
- RPOC / 0444-19-TLV
- Conditions
- Abortion Induced Complicated
- Keywords
- RPOC, induced abortion, misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 28 Dec 2020 (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.
Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion
Detailed description
An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectant | No intervention | –No medication is assigned. |
| Medical | Experimental | Drug: MisoprostolSL 800 mcg Misoprostol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 < age < 45 year old
- Thick irregular endometrium >12 mm on trans-vaginal ultrasound
Key exclusion criteria (4 listed)
- Endometritis
- Cervical opening > 1 cm
- Uterine abnormalities
- Contraindication to Misoprostol treatment
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 |
|---|---|---|
| MisoprostolAlso: Cytotecsl 800 mcg misoprostol | Drug | Medical |
Primary outcome
RPOC rate
Time frame: 2 months
RPOC rate in repeat ultrasound scan performed 5 weeks after randomization
2 secondary outcomes
Adhesions
Time frame: 2 months
Bleeding
Time frame: 2 months
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 3 May 2022.
- Background: PubMed 16707509Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage: expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment (MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. doi: 10.1136/bmj.38828.593125.55. Epub 2006 May 17.
- Background: PubMed 14747165Bagratee JS, Khullar V, Regan L, Moodley J, Kagoro H. A randomized controlled trial comparing medical and expectant management of first trimester miscarriage. Hum Reprod. 2004 Feb;19(2):266-71. doi: 10.1093/humrep/deh049.
- Background: PubMed 24417417Ashwal E, Melamed N, Hiersch L, Wiznitzer A, Yogev Y, Peled Y. The incidence and risk factors for retained placenta after vaginal delivery - a single center experience. J Matern Fetal Neonatal Med. 2014 Dec;27(18):1897-900. doi: 10.3109/14767058.2014.883374. Epub 2014 Feb 4.
- Background: PubMed 28891361Anteby M, Many A, Ashwal E, Yogev Y, Shinar S. Risk factors and complications of manual placental removal after vaginal delivery - how common are additional invasive procedures? J Matern Fetal Neonatal Med. 2019 Feb;32(3):384-388. doi: 10.1080/14767058.2017.1379071. Epub 2017 Sep 19.
- Derived from this study: PubMed 35752301Tzur Y, Berkovitz-Shperling R, Goitein Inbar T, Bar-On S, Gil Y, Levin I, Cohen A. Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study. Am J Obstet Gynecol. 2022 Oct;227(4):599.e1-599.e9. doi: 10.1016/j.ajog.2022.06.025. Epub 2022 Jun 23.
- Individual participant dataSharing planned: Yes. on line sharing via secured system
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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.
Yossi Tzur, MD study director
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Abortion Induced Complicated, run by Tel-Aviv Sourasky 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 2 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 3 May 2022. 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.
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?
RPOC rate (time frame: 2 months). 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 NCT04685694, which also lists 5 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 3 May 2022.