Идёт набор NCT07088510

Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

Без фазы С лечением Miscarriage in First Trimester

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Hysteroscopic resection, Manual Vacuum Aspiration.
Кому может быть актуально: Состояния в реестре: Miscarriage in First Trimester. Базовые параметры: 18 лет — 55 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Randomized Control Trial Investigating Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy

Обзор

Early pregnancy loss happens when a pregnancy that is not developing properly is found on an ultrasound before 12 weeks and 6 days. This type of loss occurs in about 10% of pregnancies. There are three main ways to treat this: waiting for it to pass naturally, using medication, or having surgery. Surgery is the most effective, working 99% of the time, compared to waiting (80% effective in 8 weeks) and medication (71-84% effective). Currently, surgery involves dilation of the cervix and curettage (removal of pregnancy tissue) with suction provided either from a manual hand-held pump or a machine. For the purposes of this study, a manual vacuum aspirator (or hand-held pump) will be used with ultrasound guidance. There is also another method called hysteroscopic resection, where the doctor uses a special camera to directly see and remove any pregnancy tissue from your uterus. Patients often want the quickest way to resolve the pregnancy loss, and physicians are unsure which surgical method is the best. It's also unclear if one type of surgery causes less scar tissue inside the uterus, affects the ability to test the tissue for genetic issues, or impacts how soon a patient can start fertility treatments again. This study aims to find out if hysteroscopic resection provides faster resolution and creates less scar tissue compared to the manual vacuum aspiration.

Подробное описание

Early pregnancy loss is when a nonviable intrauterine pregnancy is diagnosed on ultrasound prior to 12 weeks and 6 days of gestation and occurs in 10% of pregnancies. There are typically three treatment modalities: expectant management, medical management, or surgical management. Surgical management is 99% effective in comparison to expectant management (80% resolution within 8 weeks) and medical management (71-84%). Current standard surgical management includes manual vacuum aspiration or suction dilation and curettage with or without ultrasound guidance. Hysteroscopic resection of retained products of conception (RPOC) has been studied. A recent randomized control trial comparing this to vacuum curettage showed hysteroscopic resection of RPOC had an increase in completeness of removal of the RPOC and decreased need for additional treatment with either a second hysteroscopy or vacuum curettage. Although detailed in 1 case report and performed nationally, hysteroscopic resection in comparison to manual vacuum aspiration of early pregnancy loss has not been investigated. Potential benefits of hysteroscopic resection in comparison to manual vacuum aspiration include faster return to negative bHCG, decreased risk of intrauterine adhesion formation post-operatively, and decreased risk of retained products of conception. Furthermore, 50% of early pregnancy losses are due to fetal chromosomal abnormalities. Thus, diagnosis of a chromosomal abnormality can both provide information for the patient and allow for guidance of pregnancy treatment in the future. A retrospective chart review determined that obtaining fetal genetics is less likely to be contaminated with maternal tissue and is more likely to detect fetal chromosomes when the products of conception were biopsied hysteroscopically prior to suction dilation and curettage rather than when the pregnancy is terminated solely with suction dilation and curettage. Thus, hysteroscopic resection of early pregnancy loss may provide cytogenetic information that may not be obtained with a manual vacuum aspiration (similar technique as suction dilation and curettage, using manual suction instead of electric suction). This study aims to find out if hysteroscopic resection provides faster resolution of the pregnancy loss, creates less scar tissue, and improves genetic testing in comparison to manual vacuum aspiration.

Вмешательства

Процедура Hysteroscopic resection
Participants will undergo a hysteroscopy where a camera is placed on the inside of the uterus. Then a resector will be used to remove the pregnancy loss under direct visualization.
Процедура Manual Vacuum Aspiration
Participants will undergo a manual vacuum aspiration with ultrasound guidance for treatment of early pregnancy loss. This is when pregnancy loss is suctioned by a machine from the uterus.

Первичные конечные точки

Change in beta human chorionic gonadotropin (bHCG) levels as measured by blood test [Срок оценки: Baseline, 1 week post operation, 2 week post operation, 3 week post operation, 4 week post operation, 5 week post operation]

Вторичные конечные точки (7)

Number of uterine adhesions detected by follow up hysteroscopy [Срок оценки: 4 weeks post operation]
Number of post operative bleeding incidences as measured by nurse observation [Срок оценки: Up to 1 hour post operation]
Time in minutes to complete procedure [Срок оценки: Up to 30 minutes]
Number of retained products of conception as seen on follow up hysteroscopy [Срок оценки: 1 month post operation]
Number of additional treatments needed as measured by follow up hysteroscopy [Срок оценки: 1 month post operation]
Time in months to next fertility treatment [Срок оценки: Up to 12 months]
Number of completed cytogenetic results as measured genetic testing [Срок оценки: Up to 1 month post operation]

Критерии участия

Критерии включения

Adult women age 18-55
Ultrasound Diagnosis of Early Pregnancy Loss
< 9 weeks gestational age as determined by ultrasound
Singleton non-viable pregnancy
Stated and willingness to comply with all study procedures and availability for the duration of the study
Provision of signed and dated informed consent form
Chose a surgical method of management for fetal loss