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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
580
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.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGNumber 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
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