Early Safety Trial of Reduction Surgery in Multiple Pregnancies

UMIN ID: UMIN000053959

Registered date:05/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Multiple prengancy
• Date of first enrollment: 2024/04/05
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Reduction surgery is performed by puncturing the uterus with a needle guided by transabdominal ultrasound between the 11th and 13th weeks of pregnancy and injecting potassium chloride into the fetal heart cavity.

Outcome(s)

• Primary Outcome: Successful rate of selective reduction surgery on the day after the operation
• Secondary Outcome: 1. Number of surviving fetuses one week after the surgery. 2. Psychological evaluation of subjects one week after the surgery. 3. Number of adverse events occurring within one week post-surgery.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 50years-old
• Gender: Female
• Exclude criteria: 1. Individuals who test positive for HIV antibodies, HCV antibodies, or HBs antigen. 2. Individuals with psychiatric illness or symptoms that make participation in and continuation of the trial difficult. 3. Individuals with poor overall health status, classified under the American Society of Anesthesiologists Preoperative Physical Status Classification as ASA-PS Class 3, 4, 5, or 6.

Related Information

• Primary Sponsor: The University of Osaka
• Source(s) of Monetary Support: The University of Osaka