A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion
1 other identifier
interventional
580
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
February 20, 2026
May 1, 2025
6 years
June 3, 2025
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Secondary Outcomes (7)
Time to Expulsion of Gestational Sac Following Medication Treatment
From the first dose of misoprostol to expulsion, assessed up to 72 hours
Intraoperative Blood Loss During Surgical Treatment
During the surgical procedure
Operative Time for Surgical Treatment
During the surgical procedure
Number of Participants with Adverse Drug Reactions During Medication Treatment
From the first dose of medication to 7 days after treatment completion
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
- +2 more secondary outcomes
Study Arms (4)
Surgical abortion routine group
EXPERIMENTALNo 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.
Medical abortion routine group
EXPERIMENTALPatients 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.
Medical abortion experimental group
EXPERIMENTALPatients 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.
Surgical abortion experimental group
EXPERIMENTALEstradiol 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2025
First Posted
February 20, 2026
Study Start
January 1, 2024
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2035
Last Updated
February 20, 2026
Record last verified: 2025-05