Cesarean Section ComplicationsNCT06219538
DAISY Uterine Drain Device Evaluation
A study testing DAISY Uterine Drain in people with Cesarean Section Complications and Post Partum Hemorrhage, run by Raydiant Oximetry, Inc. at 1 site in United States.
Trial 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), who… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Post Partum Hemorrhage, Uterine Atony With Hemorrhage
- What is being tested?
- DAISY Uterine Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants consist of women undergoing planned CD for reasons unrelated to this study.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Section Complications, Post Partum Hemorrhage, Uterine Atony With Hemorrhage, Uterine Bleeding
- Being tested
- DAISY Uterine Drain
- Keywords
- uterine drain, PPH
- Medical subject headings
- Postpartum Hemorrhage, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAISY Uterine DrainDevice
Insertion of the DAISY Uterine Drain and connection to wall suction in women who have undergone a Caesarean Delivery,
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Ten women in whom the Daisy Drain is placed. Receives: Device: DAISY Uterine Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of surgery (preoperative) and one day post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start22 May 2024
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants consist of women undergoing planned CD for reasons unrelated to this study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raydiant Oximetry, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tetsuya Kawakita, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219538
- Sponsor's protocol ID
- CP2400
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2024
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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. 2026 Jul;43(9):1253-1255. doi: 10.1055/a-2752-8798. Epub 2025 Nov 24.
PubMed 41285413
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAISY Uterine Drain: Device Evaluation With Standard Wall Suction
- ClinicalTrials.gov ID
- NCT06219538
- Acronym / sponsor ID
- CP2400
- Conditions
- Cesarean Section Complications, Post Partum Hemorrhage, Uterine Atony With Hemorrhage, Uterine Bleeding
- Keywords
- uterine drain, PPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Raydiant Oximetry, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants consist of women undergoing planned CD for reasons unrelated to this study.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: DAISY Uterine DrainTen women in whom the Daisy Drain is placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The participants consist of women undergoing planned CD for reasons unrelated to this study.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAISY Uterine DrainInsertion of the DAISY Uterine Drain and connection to wall suction in women who have undergone a Caesarean Delivery, | Device | Interventional |
Primary outcome
Device Evaluation
Time frame: Day of surgery (preoperative) and one day post procedure
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41285413Kawakita 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. 2026 Jul;43(9):1253-1255. doi: 10.1055/a-2752-8798. Epub 2025 Nov 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetsuya Kawakita, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAISY Uterine Drain in people with Cesarean Section Complications and Post Partum Hemorrhage, run by Raydiant Oximetry, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Evaluation (time frame: Day of surgery (preoperative) and one day post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.