An interventional study of Control group and Conventional dose of estrogen in Missed Abortion and Early Pregnancy Failure, sponsored by The Third Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by The Third Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
This study's planned enrollment of 580 is above the median of 110 across 41 interventional studies indexed under Abortion, Missed.
Browse Abortion, Missed studies →The Third Xiangya Hospital of Central South University is the lead sponsor of 99 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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.
Drug: Control group · Drug: Conventional dose of estrogen · Drug: High-dose estrogen
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.
Drug: Control group · Drug: Conventional dose of estrogen · Drug: High-dose estrogen
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.
Drug: Control group · Drug: Conventional dose of estrogen · Drug: High-dose estrogen
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.
Drug: Control group · Drug: Conventional dose of estrogen · Drug: High-dose estrogen
No estrogen supplementation
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.
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.
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.
Time frame: 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.
Time frame: At 3 months after treatment (on the 16th-20th day of the third menstrual cycle post-treatment)
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.
Time frame: From the first dose of misoprostol to expulsion, assessed up to 72 hours
Intraoperative Blood Loss During Surgical Treatment
Estimated blood loss (in mL) during hysteroscopic or suction curettage.
Time frame: During the surgical procedure
Operative Time for Surgical Treatment
Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year
Started Jan 2024 (actual). Primary completion is estimated for Jan 2030, 72 months after the start.
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Studies of the drug tested here: Estrogens
The Third Xiangya Hospital of Central South University