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NCT Number: NCT07422506

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.

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Key information

Conditions

Missed Abortion Abortion, Missed Abortion, Spontaneous Early Pregnancy Failure Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Dabao Xu

CONTACT

[email protected]

13017386201

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group

Drug

No estrogen supplementation

Conventional dose of estrogen

Drug

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.

High-dose estrogen

Drug

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.

Primary outcomes

  1. Number of Participants with Complete Abortion Following Treatment for Early Missed Abortion

    Time frame: 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.

  2. Number of Participants with Intrauterine Adhesions (IUA) at 3 Months Post-Treatment

    Time frame: 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 outcomes

  1. Time to Expulsion of Gestational Sac Following Medication Treatment

    Time frame: 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.

  2. Intraoperative Blood Loss During Surgical Treatment

    Time frame: During the surgical procedure

    Estimated blood loss (in mL) during hysteroscopic or suction curettage.

  3. Operative Time for Surgical Treatment

    Time frame: During the surgical procedure

    Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal.

  4. Number of Participants with Adverse Drug Reactions During Medication Treatment

    Time frame: 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.

  5. Change from Baseline in Menstrual Blood Volume at 3 Months Post-Treatment

    Time frame: 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).

  6. Number of Participants with Residual Gestational Tissue at 14 Days Post-Treatment

    Time frame: 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.

  7. Number of Participants Achieving Pregnancy within 1 Year after Attempting Conception

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dabao Xu

CONTACT

[email protected]

13017386201

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2035
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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