A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion

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 Overview

• Status: Recruiting
• Conditions: Missed Abortion; Early Pregnancy Failure
• Intervention / Treatment: Drug: Control group; Drug: Conventional dose of estrogen; Drug: High-dose estrogen

• Study Type: Interventional
• Enrollment (Estimated): 580
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dabao Xu; Phone Number: 13017386201; Email: forxudabao@126.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The Third Xiangya Hospital of Central South University
      • Contact: Dabao Xu; Phone Number: 13017386201; Email: forxudabao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical abortion routine group; 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; No estrogen supplementation; Drug: Conventional 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.; Drug: High-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.
Experimental: Medical abortion routine group; 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; No estrogen supplementation; Drug: Conventional 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.; Drug: High-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.
Experimental: Medical abortion experimental group; 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; No estrogen supplementation; Drug: Conventional 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.; Drug: High-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.
Experimental: Surgical abortion experimental group; 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; No estrogen supplementation; Drug: Conventional 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.; Drug: High-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the surgical procedure
Operative Time for Surgical Treatment	Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal.	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.	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).	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.	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.	From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035

Study Registration Dates

• First Submitted: June 3, 2025
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Pharmacologic Actions; Chemical Actions and Uses; Estrogens; Control Groups
• Other Study ID Numbers: xy3-EMA-Xu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No