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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorThe Third Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

580 Participants
are divided into 4 treatment groups
Group A: Surgical abortion routine groupExperimental treatment 3 interventions
Group B: Medical abortion routine groupExperimental treatment 3 interventions
Group C: Medical abortion experimental groupExperimental treatment 3 interventions
Group D: Surgical abortion experimental groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 14 days after initiation of treatment (medication or surgery)
2

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)

Secondary outcomes

1

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
2

Intraoperative Blood Loss During Surgical Treatment

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

Time frame
During the surgical procedure
3

Operative Time for Surgical Treatment

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

Time frame
During the surgical procedure
4

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

Other outcomes

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