AcupunctureNCT05998421
The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion
A study testing acupuncture and routine aspirin and heparin treatment in people with Acupuncture and Recurrent Spontaneous Abortion, run by Jianmei Xia at 1 site in China.
Trial summary
Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in clinical practice to treat infertility and abortion. The role of acupuncture in the treatment of infertility is still unclear. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Acupuncture, Recurrent Spontaneous Abortion, Ultrasound Therapy
- What is being tested?
- acupuncture and routine aspirin and heparin treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 29 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- had a previous RSA history;
- had a normal body mass index (BMI) of 18-25 kg/m2;
- had no acute infection of the abdomen and low back skin;
- had no history of liver or kidney disease.
Who cannot join
- acute infection in the abdomen or lower back
- planning assisted reproductive technologies (ART) in the next 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial
Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in clinical practice to treat infertility and abortion. The role of acupuncture in the treatment of infertility is still unclear. The investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected.
Read the detailed description
To better illustrate the effectiveness and mechanism of acupuncture in infertility, especially in RSA patients, the investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected. The investigators hypothesized that acupuncture could promote and improve pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. To our knowledge, it has never been reported before.
- Being tested
- acupuncture, routine aspirin and heparin treatment
- Medical subject headings
- Abortion, Spontaneous, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Seirin 0.2-×30-mm acupuncture needles were used. First, needles were inserted into Shenting (GV 24) and bilateral Benshen (G 13) to relieve uneasiness of mind. Then, they were inserted into Chung wan (cv 12), Qihai (CV6), Guan yuan, chung chi (cv 3), bilateral Guiai (S 29) and Zigong (Extra 16) to recuperate energy. Finally, bilateral Tsusanli (st 36), Yinlingch'uan (sp 9) and San yin chiao (sp 6) were used to soothe the liver and tonify the spleen and kidney. Each acupuncture treatment session lasted 30 minutes, with mostly bilateral needle retention over 20-30 minutes for evens techniques.
routine aspirin and heparin treatmentDrug
The patients accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| the drug group (control group) | Active comparator | The patients in the control group accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day. Receives: Drug: routine aspirin and heparin treatment |
| the drug-accompanied-by-acupuncture group (acupuncture group) | Experimental | The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Receives: Procedure: acupuncture; Drug: routine aspirin and heparin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion
The pregnancy outcome of each patient was followed-up. The outcomes of natural pregnancy include normal clinical pregnancy(intrauterine pregnancy and pregnancy week ≥28) and adverse pregnancy. The latter includes biochemical pregnancy, spontaneous abortion and ectopic gestation.
Measured: average of 1 year
The change of blood indicators related to blood coagulation function after acupuncture1
Changes in blood indicators related to blood coagulation function, such as platelet maximum aggregation rate (MAR, inducted by arachidonic acid (AA) and adenosine diphosphate (ADP)), were also detected before and after treatment.
Measured: average of half of a year
The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
Patients in both groups were scheduled for vaginal ultrasound in the mid luteal phase to monitor the blood flow impedance in the uterine arteries before and after each treatment cycle, measured as the uterine artery (UA) systolic/diastolic (S/D) blood flow ratio.
Measured: average of half of a year
The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle
Generalized anxiety disorder (GAD-7) was used to assess patients' mental anxiety status. Each item has a score of 0-3, totaling 7 items, with a total score of 0-21. The higher the score, the more severe it becomes.
Measured: average of half of a year
The change of blood indicators related to blood coagulation function after acupuncture2
Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.
Measured: average of half of a year
The change of blood indicators related to blood coagulation function after acupuncture3
Changes in blood indicators related to blood coagulation function, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), were also detected before and after treatment.
Measured: average of half of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion29 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianmei Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianmei Xia, First People's Hospital of Hangzhou
- Investigators
- Jianmei Xia, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998421
- Sponsor's protocol ID
- 2023003
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT05998421
- Acronym / sponsor ID
- 2023003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Jianmei XiaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 29 Jul 2023 (actual)
- First posted
- 21 Aug 2023 (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.
Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in clinical practice to treat infertility and abortion. The role of acupuncture in the treatment of infertility is still unclear. The investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected.
Detailed description
To better illustrate the effectiveness and mechanism of acupuncture in infertility, especially in RSA patients, the investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected. The investigators hypothesized that acupuncture could promote and improve pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. To our knowledge, it has never been reported before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the drug group (control group) | Active comparator | Drug: routine aspirin and heparin treatmentThe patients in the control group accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day. |
| the drug-accompanied-by-acupuncture group (acupuncture group) | Experimental | Procedure: acupuncture, Drug: routine aspirin and heparin treatmentThe patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- had a previous RSA history;
- had a normal body mass index (BMI) of 18-25 kg/m2;
- had no acute infection of the abdomen and low back skin;
- had no history of liver or kidney disease.
Key exclusion criteria (2 listed)
- acute infection in the abdomen or lower back
- planning assisted reproductive technologies (ART) in the next 3 months
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 |
|---|---|---|
| acupunctureThe patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Seirin 0.2-×30-mm acupuncture needles were used. First, needles were inserted into Shenting (GV 24) and bilateral Benshen (G 13) to relieve uneasiness of mind. Then, they were inserted into Chung wan (cv 12), Qihai (CV6), Guan yuan, chung chi (cv 3), bilateral Guiai (S 29) and Zigong (Extra 16) to recuperate energy. Finally, bilateral Tsusanli (st 36), Yinlingch'uan (sp 9) and San yin chiao (sp 6) were used to soothe the liver and tonify the spleen and kidney. Each acupuncture treatment session lasted 30 minutes, with mostly bilateral needle retention over 20-30 minutes for evens techniques. | Procedure or surgery | the drug-accompanied-by-acupuncture group (acupuncture group) |
| routine aspirin and heparin treatmentThe patients accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day. | Drug | the drug group (control group), the drug-accompanied-by-acupuncture group (acupuncture group) |
Primary outcome
The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion
Time frame: average of 1 year
The pregnancy outcome of each patient was followed-up. The outcomes of natural pregnancy include normal clinical pregnancy(intrauterine pregnancy and pregnancy week ≥28) and adverse pregnancy. The latter includes biochemical pregnancy, spontaneous abortion and ectopic gestation.
The change of blood indicators related to blood coagulation function after acupuncture1
Time frame: average of half of a year
Changes in blood indicators related to blood coagulation function, such as platelet maximum aggregation rate (MAR, inducted by arachidonic acid (AA) and adenosine diphosphate (ADP)), were also detected before and after treatment.
The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
Time frame: average of half of a year
Patients in both groups were scheduled for vaginal ultrasound in the mid luteal phase to monitor the blood flow impedance in the uterine arteries before and after each treatment cycle, measured as the uterine artery (UA) systolic/diastolic (S/D) blood flow ratio.
The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle
Time frame: average of half of a year
Generalized anxiety disorder (GAD-7) was used to assess patients' mental anxiety status. Each item has a score of 0-3, totaling 7 items, with a total score of 0-21. The higher the score, the more severe it becomes.
The change of blood indicators related to blood coagulation function after acupuncture2
Time frame: average of half of a year
Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.
The change of blood indicators related to blood coagulation function after acupuncture3
Time frame: average of half of a year
Changes in blood indicators related to blood coagulation function, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), were also detected before and after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jianmei Xia principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and routine aspirin and heparin treatment in people with Acupuncture and Recurrent Spontaneous Abortion, run by Jianmei Xia 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion (time frame: average of 1 year). The study lists 6 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 21 Aug 2023.