About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
①Age 18-40 years old; ②Early pregnancy missed abortion confirmed by imaging and laboratory tests; ③All indicators of routine examinations before treatment are within the normal range, and there are no serious systemic diseases; ④No indications for emergency curettage; ⑤Good compliance, follow-up observation as required (prospective study).
Disqualifiers
①Contraindications to medical abortion; ②Those who are allergic to estrogen and have contraindications to the use of estrogen; ③Those who cannot be followed up according to the follow-up plan; ④Thromboembolic diseases, known or suspected history of breast cancer, hormone-dependent tumors, etc.; ⑤Vaginal bleeding exceeds the usual menstrual volume; ⑥Those with severe heart, liver and kidney diseases; ⑦Accompanied by serious internal and surgical diseases, malignant tumors or mental illnesses, and cannot cooperate.
Trial design
Parallel
Treatments tested in this trial
Control group
DrugNo estrogen supplementation
Conventional dose of estrogen
Drug1 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.
High-dose estrogen
Drug1 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Intraoperative Blood Loss During Surgical Treatment
Estimated blood loss (in mL) during hysteroscopic or suction curettage.
Operative Time for Surgical Treatment
Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal.
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.
Sponsors and contacts
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