Intracervical Vasopressin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intracervical injection of Vasopressin, Intracervical Injection of saline.
- Who it may be relevant to
- Registry conditions: Retained Products of Conception. Basic parameters: 18 years — 51 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intracervical Vasopressin for Completion of Hysteroscopic Removal of Retained Products of Conception
Overview
This randomized study looks at whether using a medicine injected into the cervix of the uterus (intracervical), called vasopressin, helps to achieve better removal of retained products of conception (RPOC). RPOC means that after a pregnancy has ended (through miscarriage, abortion, or delivery), some parts of the pregnancy tissue, usually from the placenta or fetus, have stayed in the uterus. A hysteroscopic removal of RPOC is one type of treatment. This is a surgical procedure where a doctor uses a small camera attached to a thin tube (called a hysteroscope) to look inside the uterus. The main goal of the study is : • To add to the existing research through this study to see if the injection of intracervical vasopressin leads to improved completion rates of hysteroscopic management of RPOC. Participants will: • would be randomized to receive either vasopressin intracervical injection or a placebo injection (non-active saline) during your procedure. Information from the procedure will be collected from the participant's medical record.
Detailed description
This double-blinded randomized control trial is designed to evaluate if intraoperative injection of intracervical vasopressin into the cervix will allow for completion of hysteroscopic removal of retained products of conception. This will be measured by surgical completion comparing patients who received intracervical vasopressin and those receiving placebo. Surgical completion is defined by completing the procedure without having to convert to suction of tissue due to bleeding or poor visualization. Secondary outcome measures include intraoperative bleeding, operative time, fluid deficit, and deficit volume.
Interventions
- Drug Intracervical injection of Vasopressin
Intracervical injection of Vasopressin - Drug Intracervical Injection of saline
Intracervical Injection of saline
Primary outcome measures
- Completion of procedure hysteroscopically [Time frame: from start of procedure to end of procedure]
Secondary outcome measures (3)
- Intraoperative Bleeding [Time frame: from start of procedure to end of procedure]
- Operative time [Time frame: time from insertion of hysteroscope to procedure completion]
- fluid deficit volume [Time frame: from start of procedure to end of procedure]
Eligibility criteria
Inclusion criteria
- Women
- Aged 18-51
- Undergoing surgical management for retained products of conception, postpartum retained products of conception or 1st trimester missed or incomplete abortion
Exclusion criteria
- Hemodynamic instability
- Active hemorrhage- soaking pad/hour
- Allergy to vasopressin
- Concern for intrauterine arteriovenous malformation
- Inability to consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The OB/GYN Center — Greenville
Identifiers
NCT: NCT07102615 · 2269142