Early Pregnancy Failure, Missed Abortion
Conditions
Brief summary
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.
Interventions
DRUGControl group
No estrogen supplementation
DRUGConventional dose of estrogen
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.
DRUGHigh-dose estrogen
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.
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Complete Abortion Following Treatment for Early Missed Abortion | Within 14 days after initiation of treatment (medication or surgery) | 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 | At 3 months after treatment (on the 16th-20th day of the third menstrual cycle 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Expulsion of Gestational Sac Following Medication Treatment | From the first dose of misoprostol to expulsion, assessed up to 72 hours | 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 | During the surgical procedure | Estimated blood loss (in mL) during hysteroscopic or suction curettage. |
| Operative Time for Surgical Treatment | During the surgical procedure | Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal. |
| Number of Participants with Adverse Drug Reactions During Medication Treatment | From the first dose of medication to 7 days after treatment completion | Adverse drug reactions include nausea, vomiting, diarrhea, fever, chills, allergic reactions, and any other events related to mifepristone, misoprostol, or estradiol valerate. |
| Change from Baseline in Menstrual Blood Volume at 3 Months Post-Treatment | Baseline (self-reported usual menstrual volume before pregnancy) and at 3 months after 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). |
| Number of Participants with Residual Gestational Tissue at 14 Days Post-Treatment | At 14 days after 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. |
| Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception | From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year | Pregnancy is defined as a positive serum β-hCG test and confirmed intrauterine gestational sac by ultrasound. |
Countries
China
Contacts
CONTACTDabao Xu
Outcome results
None listed