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At present, there is no unified standard for the treatment of missed abortion in clinical practice. This study intends to collect clinical data of this type of disease to compare the efficacy of different treatments, and on this basis, presuppose the synergistic effect of different doses of estrogen in the process of drug induction, conduct statistical analysis of the efficacy, evaluate whether the treatment plan can achieve the therapeutic effect while reducing the occurrence of complications, and provide an effective basis for the subsequent clinical treatment of missed abortion.
This study is divided into two parts. The first part is a retrospective analysis to explore the differences between missed abortion surgery and drug treatment, clinical efficacy and reproductive outcomes; the second part is a prospective study to explore the effects of different doses of estrogen combined with surgery or drug abortion on the efficacy of missed abortion in early pregnancy, and explore the best clinical treatment method for missed abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical abortion routine group | Experimental | No estradiol valerate tablets were taken before curettage, and hysteroscopic curettage was performed directly under B-ultrasound guidance. For patients who choose direct laparoscopic surgery, the intraoperative position is the lithotomy position of the bladder, and the anesthesia method is intravenous general anesthesia. Normal saline is used as the dilator fluid, and the dilator pressure is maintained at 110-120 mmHg. The hysteroscope enters the uterine cavity through the cervix, clearly observing the uterine cavity condition, exposing the pregnancy tissue, determining the location, size and relationship with the uterine wall of the pregnancy tissue, then expanding the cervix to size 7.5 with an expansion rod, inserting a 7mm suction tube for low negative pressure aspiration of the uterine cavity for two weeks. Then reinsert the hysteroscope, if there is residual pregnancy tissue, use a micro forceps to remove the remaining residual tissue under direct vision. |
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| Medical abortion routine group | Experimental | Patients who choose to use mifepristone combined with misoprostol for medical abortion are given mifepristone 50mg, Bid, orally for 2 consecutive days, and misoprostol 600μg vaginally or 400μg sublingually on the third day. No pregnancy products are discharged after medication, and the medication is repeated once every 3h (oral) or 6h (vaginal medication). The method of taking is to take 400μg of misoprostol sublingually, and the method of intravaginal medication is to place 400μg of misoprostol. Patients who have previously met this treatment method are included in the drug treatment group. |
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| Medical abortion experimental group | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Drug | No estrogen supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Complete Abortion Following Treatment for Early Missed Abortion | Complete abortion is defined as complete expulsion of gestational tissue without the need for subsequent surgical evacuation, confirmed by transvaginal ultrasound (no intrauterine pregnancy remnants) and serum β-hCG normalization. | Within 14 days after initiation of treatment (medication or surgery) |
| Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment | Intrauterine adhesions are diagnosed by three-dimensional transvaginal ultrasound or hysteroscopy. Adhesions are graded according to the American Fertility Society (AFS) classification. | At 3 months after treatment (on the 16th-20th day of the third menstrual cycle post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Expulsion of Gestational Sac Following Medication Treatment | Time interval (in hours) from administration of the first dose of misoprostol to complete expulsion of the gestational sac. | From the first dose of misoprostol to expulsion, assessed up to 72 hours |
| Intraoperative Blood Loss During Surgical Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dabao Xu | Contact | 13017386201 | forxudabao@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2023 | Feb 11, 2026 |
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Patients who choose to use mifepristone combined with misoprostol for medical abortion are given mifepristone 50mg, Bid, for 2 consecutive days, and misoprostol 600μg vaginally or 400μg sublingually on the third day. No pregnancy products are discharged after medication, and the medication is repeated once every 3h (oral) or 6h (vaginal medication). The method of taking is to take misoprostol 400μg sublingually, and the method of intravaginal medication is to place misoprostol 400μg. Estradiol valerate tablets are added daily for treatment, 2mg Bid, for 3 days.
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| Surgical abortion experimental group | Experimental | Estradiol valerate tablets were taken orally for 3 days before curettage, with a dose of 2mg Bid, and hysteroscopic curettage was performed under B-ultrasound guidance on the 4th day. |
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| Conventional dose of estrogen | Drug | 1 day after medical abortion, give oral estradiol valerate, 1 mg Bid, for 21 days, and add dydrogesterone 10 mg Bid for the next 7 days. Take it in a cycle starting from the 5th day of the next menstruation for a total of 2 cycles. |
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| High-dose estrogen | Drug | 1 day after abortion, give oral estradiol valerate, 2 mg Bid, for 21 days, and add dydrogesterone 10 mg Bid for the next 7 days. Take it in a cycle starting from the 5th day of the next menstruation for a total of 2 cycles. |
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Estimated blood loss (in mL) during hysteroscopic or suction curettage. |
| During the surgical procedure |
| Operative Time for Surgical Treatment | Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal. | During the surgical procedure |
| Number of Participants with Adverse Drug Reactions During Medication Treatment | Adverse drug reactions include nausea, vomiting, diarrhea, fever, chills, allergic reactions, and any other events related to mifepristone, misoprostol, or estradiol valerate. | From the first dose of medication to 7 days after treatment completion |
| Change from Baseline in Menstrual Blood Volume at 3 Months Post-Treatment | Menstrual blood volume is assessed subjectively by the patient using a pictorial blood loss assessment chart (PBAC) or semi-quantitative scale (increased, unchanged, decreased compared to baseline). | Baseline (self-reported usual menstrual volume before pregnancy) and at 3 months after treatment |
| Number of Participants with Residual Gestational Tissue at 14 Days Post-Treatment | Residual gestational tissue is defined as any intrauterine hyperechoic mass with a maximum diameter ≥10 mm or with vascularity on Doppler ultrasound, requiring further medical or surgical intervention. | At 14 days after treatment |
| Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception | Pregnancy is defined as a positive serum β-hCG test and confirmed intrauterine gestational sac by ultrasound. | From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000030 | Abortion, Missed |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D004967 | Estrogens |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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