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Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D&C) in the management of first trimester missed abortion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative Hysteroscopy | Experimental | Hysteroscopic separation |
|
| Dilation and Curettage | Active Comparator | Curettage separation |
|
| Feasibility and safety | Experimental | The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operative Hysteroscopy | Procedure | Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retained product of conception (RPOC) | RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yossi Tzur, M.D. | Contact | +97236925603 | yossitzur@gmail.com | |
| Gilad Rattan, M.D. | Contact | +97236925603 | giladrattan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yariv Yogev, M.D. | Tel-Aviv Sourasky Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lis Maternity Hospital, Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10864550 | Background | 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. | |
| 12620443 | Background | Wang 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. |
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Study protocol and statistical analysis plan
within 6 months of completion
Yes
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D000030 | Abortion, Missed |
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
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| D&C | Procedure | Separation of the non-viable gestational sac from the uterine wall through dilation and curettage |
|
| Operative Hysteroscopy - safety and feasibility | Procedure | Operative hysteroscopy - safety and feasibility phase |
|
| 30157093 | Background | American 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. |
| 16120856 | Background | Zhang 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. |
| 24082042 | Background | Hooker 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. |
| 18094891 | Background | Salzani 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. |
| D052776 | Female Urogenital Diseases |
| D000091662 | Genital Diseases |