Missed AbortionNCT07422506
A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion
A study testing Conventional dose of estrogen and High-dose estrogen in people with Missed Abortion and Early Pregnancy Failure, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Missed Abortion, Early Pregnancy Failure
- What is being tested?
- Conventional dose of estrogen and High-dose estrogen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Dabao Xu, 13017386201, forxudabao@126.com
About this study
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.
- Conditions
- Missed Abortion, Early Pregnancy Failure
- Being tested
- Control group, Conventional dose of estrogen, High-dose estrogen
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDrug
No estrogen supplementation
Conventional dose of estrogenDrug
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 estrogenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical abortion routine group | Experimental | 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. Receives: Drug: Control group; Drug: Conventional dose of estrogen; Drug: High-dose estrogen |
| Medical abortion routine group | Experimental | 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. Receives: Drug: Control group; Drug: Conventional dose of estrogen; Drug: High-dose estrogen |
| Medical abortion experimental group | Experimental | 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. Receives: Drug: Control group; Drug: Conventional dose of estrogen; Drug: High-dose estrogen |
| Surgical abortion experimental group | Experimental | 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. Receives: Drug: Control group; Drug: Conventional dose of estrogen; Drug: High-dose estrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Time interval (in hours) from administration of the first dose of misoprostol to complete expulsion of the gestational sac.
Measured: 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.
Measured: During the surgical procedure
Operative Time for Surgical Treatment
Duration of surgery (in minutes) from the start of hysteroscope insertion to withdrawal.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From the start of attempting pregnancy (after completion of treatment and at least one normal menstrual cycle) up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422506
- Sponsor's protocol ID
- xy3-EMA-Xu
- Status last verified
- May 2025
- First submitted
- 3 Jun 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion
- ClinicalTrials.gov ID
- NCT07422506
- Acronym / sponsor ID
- xy3-EMA-Xu
- Conditions
- Missed Abortion, Early Pregnancy Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgical abortion routine group | Experimental | Drug: Control group, Drug: Conventional dose of estrogen, Drug: High-dose estrogenNo 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 | Experimental | Drug: Control group, Drug: Conventional dose of estrogen, Drug: High-dose estrogenPatients 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 | Experimental | Drug: Control group, Drug: Conventional dose of estrogen, Drug: High-dose estrogenPatients 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 | Experimental | Drug: Control group, Drug: Conventional dose of estrogen, Drug: High-dose estrogenEstradiol 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupNo estrogen supplementation | Drug | Medical abortion experimental group, Medical abortion routine group, Surgical abortion experimental group, Surgical abortion routine group |
| Conventional dose of estrogen1 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 | Medical abortion experimental group, Medical abortion routine group, Surgical abortion experimental group, Surgical abortion routine group |
| High-dose estrogen1 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. | Drug | Medical abortion experimental group, Medical abortion routine group, Surgical abortion experimental group, Surgical abortion routine group |
Primary outcome
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.
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.
7 secondary outcomes
Time to Expulsion of Gestational Sac Following Medication Treatment
Time frame: From the first dose of misoprostol to expulsion, assessed up to 72 hours
Intraoperative Blood Loss During Surgical Treatment
Time frame: During the surgical procedure
Operative Time for Surgical Treatment
Time frame: During the surgical procedure
Number of Participants with Adverse Drug Reactions During Medication Treatment
Time frame: From the first dose of medication to 7 days after treatment completion
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
Number of Participants with Residual Gestational Tissue at 14 Days Post-Treatment
Time frame: At 14 days after treatment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional dose of estrogen and High-dose estrogen in people with Missed Abortion and Early Pregnancy Failure, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dabao Xu (13017386201, forxudabao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Complete Abortion Following Treatment for Early Missed Abortion (time frame: Within 14 days after initiation of treatment (medication or surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.