Spontaneous AbortionNCT04705324
Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion
A study testing Operative Hysteroscopy, D&C and Operative Hysteroscopy - safety and feasibility in people with Spontaneous Abortion and Missed Abortion, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D\&C) in the management of first trimester missed abortion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion
- What is being tested?
- Operative Hysteroscopy, D&C and Operative Hysteroscopy - safety and feasibility
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jan 2022to 20 Jan 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP).
Who cannot join
- women who electively choose to terminate pregnancy
- women who took medical treatment for missed abortion prior to recruitment
- women with known uterine abnormality
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Yariv Yogev, MD, 97236925603, yarivyogev@hotmail.com
Yossi Tzur, MD, 97236925603, yossitzur@gmail.com
About this study
Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D\&C) in the management of first trimester missed abortion.
Read the detailed description
A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D\&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.
- Conditions
- Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion, Retained Products of Conception
- Being tested
- Operative Hysteroscopy, D&C, Operative Hysteroscopy - safety and feasibility
- Medical subject headings
- Abortion, Spontaneous, Abortion, Missed, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative HysteroscopyProcedure or surgery
Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
D&CProcedure or surgery
Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
Operative Hysteroscopy - safety and feasibilityProcedure or surgery
Operative hysteroscopy - safety and feasibility phase
| Study group | Role | What they receive |
|---|---|---|
| Operative Hysteroscopy | Experimental | Hysteroscopic separation Receives: Procedure: Operative Hysteroscopy |
| Dilation and Curettage | Active comparator | Curettage separation Receives: Procedure: D&C |
| Feasibility and safety | Experimental | The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase Receives: Procedure: Operative Hysteroscopy - safety and feasibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrauterine adhesions (IUA)
IUA formation will be assessed in all participants in the follow up diagnostic hysteroscopy performed 8 weeks after the primary treatment. IUA will be classified according to the American Society for Reproductive Medicine
Measured: 2 months
Secondary outcomes (1)
Retained product of conception (RPOC)
RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment
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 posted12 Jan 2021
- Study start21 Jan 2022
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spontaneous AbortionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
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
- Yariv Yogev, M.D., Study chair, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705324
- Sponsor's protocol ID
- 0087-20-TLV
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan
Publications
Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ. 2000 Jun 24;320(7251):1708-12. doi: 10.1136/bmj.320.7251.1708.
PubMed 10864550Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0.
PubMed 12620443American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.
PubMed 30157093Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM; National Institute of Child Health Human Development (NICHD) Management of Early Pregnancy Failure Trial. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005 Aug 25;353(8):761-9. doi: 10.1056/NEJMoa044064.
PubMed 16120856Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29.
PubMed 24082042Salzani A, Yela DA, Gabiatti JR, Bedone AJ, Monteiro IM. Prevalence of uterine synechia after abortion evacuation curettage. Sao Paulo Med J. 2007 Sep 6;125(5):261-4. doi: 10.1590/s1516-31802007000500002.
PubMed 18094891
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion
- ClinicalTrials.gov ID
- NCT04705324
- Acronym / sponsor ID
- 0087-20-TLV
- Conditions
- Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion, Retained Products of Conception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 12 Jan 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.
Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D\&C) in the management of first trimester missed abortion.
Detailed description
A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D\&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Operative Hysteroscopy | Experimental | Procedure: Operative HysteroscopyHysteroscopic separation |
| Dilation and Curettage | Active comparator | Procedure: D&CCurettage separation |
| Feasibility and safety | Experimental | Procedure: Operative Hysteroscopy - safety and feasibilityThe first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP).
Key exclusion criteria (3 listed)
- women who electively choose to terminate pregnancy
- women who took medical treatment for missed abortion prior to recruitment
- women with known uterine abnormality
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 |
|---|---|---|
| Operative HysteroscopySeparation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy | Procedure or surgery | Operative Hysteroscopy |
| D&CSeparation of the non-viable gestational sac from the uterine wall through dilation and curettage | Procedure or surgery | Dilation and Curettage |
| Operative Hysteroscopy - safety and feasibilityOperative hysteroscopy - safety and feasibility phase | Procedure or surgery | Feasibility and safety |
Primary outcome
Intrauterine adhesions (IUA)
Time frame: 2 months
IUA formation will be assessed in all participants in the follow up diagnostic hysteroscopy performed 8 weeks after the primary treatment. IUA will be classified according to the American Society for Reproductive Medicine
1 secondary outcome
Retained product of conception (RPOC)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Background: PubMed 10864550Nybo Andersen AM, Wohlfahrt J, Christens P, Olsen J, Melbye M. Maternal age and fetal loss: population based register linkage study. BMJ. 2000 Jun 24;320(7251):1708-12. doi: 10.1136/bmj.320.7251.1708.
- Background: PubMed 12620443Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0.
- Background: PubMed 30157093American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899.
- Background: PubMed 16120856Zhang J, Gilles JM, Barnhart K, Creinin MD, Westhoff C, Frederick MM; National Institute of Child Health Human Development (NICHD) Management of Early Pregnancy Failure Trial. A comparison of medical management with misoprostol and surgical management for early pregnancy failure. N Engl J Med. 2005 Aug 25;353(8):761-9. doi: 10.1056/NEJMoa044064.
- Background: PubMed 24082042Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29.
- Background: PubMed 18094891Salzani A, Yela DA, Gabiatti JR, Bedone AJ, Monteiro IM. Prevalence of uterine synechia after abortion evacuation curettage. Sao Paulo Med J. 2007 Sep 6;125(5):261-4. doi: 10.1590/s1516-31802007000500002.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan
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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.
Yariv Yogev, M.D. study chair
Tel-Aviv Sourasky 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 Operative Hysteroscopy, D&C and Operative Hysteroscopy - safety and feasibility in people with Spontaneous Abortion and Missed Abortion, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yossi Tzur, M.D. (+97236925603, yossitzur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrauterine adhesions (IUA) (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 NCT04705324, which also lists 6 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 30 Mar 2023.