Clinical trial NCT06219538: DAISY Uterine Drain Device Evaluation
Official title: DAISY Uterine Drain: Device Evaluation With Standard Wall Suction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Post Partum Hemorrhage
Uterine Atony With Hemorrhage
Uterine Bleeding
Keywords: uterine drain
PPH
Lead sponsor: Raydiant Oximetry, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants consist of women undergoing planned CD, D \& C, or D \& E for reasons unrelated to this study.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom the drain is placed as "participants." Participants are pregnant women who are undergoing cesarean delivery (CD) or D \& C, who have not entered active labor, who have consented to drain placement and who have met all the inclusion/exclusion criteria. Users are staff or fellow obstetrical surgeons who will use the drain and provide the evaluation.

Detailed description: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide. (D'Alton 2020). It is estimated that 14 million cases of PPH occur each year worldwide (Rath, 2011). In the United States, PPH causes up to 12% of maternal deaths and is the leading cause of death occurring on the day of delivery (ACOG 2017; Butwick 2019; Evensen 2020; Hawkins 2020). According to the American College of Obstetricians and Gynecologists (ACOG), between 54% and 93% of PPH-associated mortality may be preventable while 70-80% of PPH is due to abnormal uterine tone (atony) (ACOG 2017). Atony involves a deficient response to physiological signals that promote uterine contraction and blood vessel compression after delivery. Contraction of the myometrium compresses the blood vessels supplying the placental bed and thereby causes mechanical hemostasis. Uterine atony following CD is a relatively common problem in the non-laboring patient because contraction of the myometrium is almost entirely absent. Restoring uterine tone can be addressed through 1) medication, 2) surgery, or 3) mechanical means. Post-partum unrecognized uterine hemorrhage due to a closed or narrow cervix that allows blood to collect in a patient undergoing a CD could lead to complications such as dangerously low blood pressure. The DAISY drain is intended to provide a channel through the cervix for fluid drainage after pelvic surgery. The DAISY device consists of a soft silicone drainage tube (proximal end) attached to a semi-flexible catheter, inserted through the hysterotomy created at the time of the CD or placed transvaginally at the time of a D \& C. If placed during a CD, the DAISY drain will be placed intraoperatively after delivery of the placenta, stabilization of the patient, and cleansing of the uterine cavity but prior to closure of the hysterotomy. The drain will be placed through the hysterotomy and threaded through the cervix and vaginal canal, out the introitus, so the distal end is accessible outside of the body. If placed during a D \& C, the device is placed transvaginally. In this study, the drain will be placed on continuous suction according to the IFU for the first two postoperative hours or more if required. At the end of the 2-hour period, the uterus will be evaluated by manual palpation and abdominal ultrasound. The abdominal ultrasound will be performed to document device placement and to assess uterine involution, approximate uterine size and uterine cavity size, presence of intrauterine clots or retained products of conception. The trained user will remove the drain after at least two hours post-surgery based on clinical management. Suction will be discontinued before removal. One method of determining if the drain is no longer needed is by checking and documenting uterine tone. If uterine tone has returned to normal as assessed by palpation, the DAISY drain may be removed.

Eligibility criteria: Inclusion Criteria:

* The participants consist of women undergoing planned CD or D \& C for reasons unrelated to this study.

Exclusion Criteria:

* Known intrauterine or cervical pathology that would interfere with device placement and/or use
* Ongoing intrauterine pregnancy
* Untreated uterine rupture
* Unresolved uterine inversion
* Current cervical cancer
* Current purulent infection of vagina, cervix, or uterus
* Retained products of conception
* Arterial bleeding requiring surgical or angiographic embolization
* Indication for hysterectomy
* Lack of study consent or unable to provide informed consent,
* Plan for IUD placement after D \& C,
* Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures

Primary outcomes:
measure: Device evaluation
timeFrame: Immediately post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Tetsuya Kawakita, MD
role: PRINCIPAL_INVESTIGATOR
References: