Assessing the Usefulness and Safety of a New Flexible Suction Device (FLEXICANN) in reducing bleeding during childbirth

Assessing the Effectiveness and Safety of a Disposable Low-Cost Flexible Suction Cannula (FLEXICANN) in Reducing Blood Loss During Childbirth A Pilot Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102227

Enrollment

100

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O720- Third-stage hemorrhage

Interventions

Intervention1: AMTSL + FLEXICANN: FLEXICANN is a sterile, flexible, 50 cm medical-grade silicone tube designed for single-use. The device features a curved distal end with 12 perforations over the fin

Eligibility

Inclusion criteria

Inclusion criteria: 1) Singleton viable gestation 2) More than or equal to 37 weeks of gestational age. 3) Able to provide informed consent prior to participation.

Exclusion criteria

Exclusion criteria: 1. Known abnormal placentation (placenta previa, accreta). 2. Known coagulopathy, bleeding disorder or current antiplatelet / anticoagulation therapies. 3. Known uterine anomaly, fibroids distorting cavity 4. Severe obstetric complications Severe preeclampsia, eclampsia, HELLP syndrome 5. Known allergy to current AMTSL uterotonics or device materials. 6. Clinical signs of active infection (fever more than 38 C, chorioamnionitis) at the time of vaginal birth. 7. Known or incidentally detected cervical or uterine malignancies. 8. Vaginal Birth After Caesarean Birth 9. Assisted Vaginal Birth

Design outcomes

Primary

Measure	Time frame
Total blood lossTimepoint: Two hours after birth	—

Secondary

Measure	Time frame
Any uterine or perineal injury, including any cervical/vaginal lacerations or severe maternal uterine infectionTimepoint: At discharge from the maternity centre;Fall in hemoglobin and hematocritTimepoint: 24 hours after birth;Postpartum blood loss more than 500 ml or 1000 mlTimepoint: After second stage of labour room shift out;Additional uterotonic useTimepoint: After second stage of labour room shift out;Secondary PPH device useTimepoint: After second stage of labour room shift out;Any surgical procedure undertaken to control bleedingTimepoint: At discharge from maternity centre;Post-partum blood transfusion ratesTimepoint: At discharge from maternity centre;Third stage of labor durationTimepoint: After second stage of labour room shift out	—

Measure

Time frame

Any uterine or perineal injury, including any cervical/vaginal lacerations or severe maternal uterine infectionTimepoint: At discharge from the maternity centre;Fall in hemoglobin and hematocritTimepoint: 24 hours after birth;Postpartum blood loss more than 500 ml or 1000 mlTimepoint: After second stage of labour room shift out;Additional uterotonic useTimepoint: After second stage of labour room shift out;Secondary PPH device useTimepoint: After second stage of labour room shift out;Any surgical procedure undertaken to control bleedingTimepoint: At discharge from maternity centre;Post-partum blood transfusion ratesTimepoint: At discharge from maternity centre;Third stage of labor durationTimepoint: After second stage of labour room shift out

—

Countries

India

Contacts

Public ContactVP Paily

Rajagiri Hospital

vppaily@gmail.com9447633707

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026