A Prospective Multicenter Observational Real-world Study of Retained Products of Conception

Summary

The purpose of this study is to explore the optimal treatment strategy for retained products of pregnancy. Compared with surgical treatment, prospectively observe whether drug-assisted expectant management until the right time for surgery reduce the occurrence of intrauterine adhesions, and thus protect fertility.

Conditions

• Retained Products of Conception
• RPOC

Interventions

PROCEDURE

Uterine curettage

Use intravenous general anesthesia (which can be assisted by laryngeal mask) (local anesthesia, epidural anesthesia or endotracheal intubation anesthesia can be selected in special cases), the patient takes the lithotomy position, the anesthesia effect is satisfactory, and the uterine distension fluid is normal saline. The uterine distension pressure is adjusted to maintain at 100-120 mmHg. It is recommended to use a diagnostic and therapeutic integrated hysteroscope with an outer diameter of \<5 mm (it is necessary to record the specific type of hysteroscope and instrument used) to enter the uterine cavity through the cervix to clarify the situation in the uterine cavity. Then explore the depth of the uterus. (Under ultrasonic monitoring) The cervical dilator sequentially dilates the cervix to 8-10 (depending on the outer diameter of the therapeutic hysteroscope used, hysteroscopic electroresection is not recommended), and select a 7mm outer diameter hysteroscope with a 3mm diameter.

DRUG

Expectant care

Patients with no contraindications to medication should take 2mg Bid of Progynova (or a similar dose of Estoril) orally until after surgery (generally, Progynova is still used for about 2-4 weeks after surgery and progesterone withdrawal bleeding is used); take Yimucao granules or Wujia Biochemical Capsules orally for 2 weeks and then stop taking the medicine; check blood β-HCG every week; check uterine and bilateral adnexa 4D color Doppler ultrasound every 2-3 weeks; until the preset surgery time is reached: 1) blood β-HCG \<50mmol/L; 2) B-ultrasound measurement of the length from the internal cervical os to the uterine fundus ≤6cm; 3) the time interval from the previous surgery is at least 4 weeks; 4) Color Doppler ultrasound indicates that the blood flow level of the pregnancy and the attachment is 1-3.

Sponsors & Collaborators

• Changsha Hospital for Maternal and Child Health Care

  collaborator OTHER

• ZhuZhou Central Hospital

  collaborator OTHER

• Xiangtan Central Hospital

  collaborator OTHER

• Xiangtan Hospital for Maternal and Child Health Care

  collaborator UNKNOWN

• Yiyang Hospital for Maternal and Child Health Care

  collaborator UNKNOWN

• The First People's Hospital of YueYang

  collaborator UNKNOWN

• The First People's Hospital of Changde City

  collaborator OTHER

• The First Affiliated Hospital of Shaoyang University

  collaborator UNKNOWN

• The First People's Hospital of Huaihua

  collaborator UNKNOWN

• Hengyang Central Hospital

  collaborator OTHER_GOV

• Chenzhou Hospital for Maternal and Child Health Care

  collaborator UNKNOWN

• Yongzhou Center Hospital

  collaborator UNKNOWN

• Hunan Provincial People's Hospital

  collaborator OTHER

• Changsha Maternal and Child Health Hospital

  collaborator UNKNOWN

• Liuyang People's Hospital

  collaborator UNKNOWN

• The Third Xiangya Hospital of Central South University

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2027-12-31

Completion

2032-12-31

Countries

• China

Study Locations