N/A
Completed N=10
DAISY Uterine Drain Device Evaluation
Cesarean Section Complications · Post Partum Hemorrhage · Uterine Atony With Hemorrhage · Uterine Bleeding
Source: ClinicalTrials.gov NCT06219538 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Device Evaluation — 1.36 g/dL
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Evaluation |
1.36 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06219538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.