DAISY Uterine Drain Device Evaluation

DAISY Uterine Drain: Device Evaluation With Standard Wall Suction

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), 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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Post Partum Hemorrhage; Uterine Bleeding; Uterine Atony With Hemorrhage
• Intervention / Treatment: Device: DAISY Uterine Drain

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. The DAISY drain is 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 is 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. In this study, the drain is 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 is evaluated by manual palpation and abdominal ultrasound. The abdominal ultrasound is 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 removes the drain after at least two hours post-surgery based on clinical management. Suction is 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The participants consist of women undergoing planned CD 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,
• Any condition (temporary or permanent) in which the investigator or user deems the patient unsuitable for the study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Ten women in whom the Daisy Drain is placed.	Device: DAISY Uterine Drain; Insertion of the DAISY Uterine Drain and connection to wall suction in women who have undergone a Caesarean Delivery,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Evaluation	This is a prospective, single-arm, device evaluation study of device use by five (5) obstetrical surgeons placing the drain with low-level suction in up to ten (10) women undergoing elective, non-emergent cesarean delivery. Hemoglobin was measured at two time points: baseline (preoperative) and 1 day post operative. The mean change in hemoglobin concentration between baseline (preoperative) values obtained on the day of surgery and postoperative day 1 was analyzed and compared to historical means in the US in 31 hospitals with 5470 participants.	Day of surgery (preoperative) and one day post procedure

Collaborators and Investigators

• Sponsor: Raydiant Oximetry, Inc.
• Investigators: Principal Investigator: Tetsuya Kawakita, MD, Eastern Virginia Medical School

Publications and helpful links

General Publications

• Kawakita T, Ray N, Brennan M, Rosen M, Saade G. A Uterine Suction Device to Prevent Postpartum Hemorrhage in Scheduled Cesarean Delivery: A Pilot Study. Am J Perinatol. 2025 Dec 4. doi: 10.1055/a-2752-8798. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Actual): April 16, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PPH; uterine drain
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Puerperal Disorders; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: CP2400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes