Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage: a Multicenter Randomized Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202204852865149

Enrollment

424

Registered

2022-04-04

Start date

2022-06-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Pregnancy and Childbirth

Interventions

Standard care

Jada System

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Delivery at 34 weeks or greater 3. Vaginal or cesarean delivery 4. Cumulative blood loss>1000ml within 24 after delivery 5. Uterine atony 6. Receipt of first-line uterotonics 7. Cervix at least 3 cm dilated at cesarean section

Exclusion criteria

Exclusion criteria: 1. Patient unwilling or unable to provide informed consent 2. Retained placenta or other known cause of postpartum hemorrhage 3. Placenta accreta spectrum 4. Coagulopathy 5. ruptured uterus 6. Surgical management immediately needed for life-threatening bleeding 7. Known contraindication for Jada System: on-going intrauterine pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomaly, current purulent infection.

Design outcomes

Primary

Measure	Time frame
Maternal survival without surgical intervention.	—

Secondary

Measure	Time frame
Time from randomization to control of bleeding ;Postpartum hemoglobin ;Change in hemoglobin from labor admission to postpartum day 1 ;Maternal transfusion of blood or blood products postpartum ;Number of units of blood products transfused ;Estimated blood loss post-randomization;Surgical procedures performed, including uterine vascular ligation, uterine compression sutures and hysterectomy. ;Maternal death postpartum ;Additional uterotonic used after randomization; Patient satisfaction score on a scale of 0 (least satisfied) to 10 (most satisfied);Composite adverse events potentially related to the Jada System, including genital tract injury, uterine perforation or rupture and endometritis.;Quality-adjusted Life-year based on the literature and Quality of Life Questionnaire (EQ-5D-5L);Incremental cost per quality-adjusted life-year	—

Measure

Time frame

Time from randomization to control of bleeding ;Postpartum hemoglobin ;Change in hemoglobin from labor admission to postpartum day 1 ;Maternal transfusion of blood or blood products postpartum ;Number of units of blood products transfused ;Estimated blood loss post-randomization;Surgical procedures performed, including uterine vascular ligation, uterine compression sutures and hysterectomy. ;Maternal death postpartum ;Additional uterotonic used after randomization; Patient satisfaction score on a scale of 0 (least satisfied) to 10 (most satisfied);Composite adverse events potentially related to the Jada System, including genital tract injury, uterine perforation or rupture and endometritis.;Quality-adjusted Life-year based on the literature and Quality of Life Questionnaire (EQ-5D-5L);Incremental cost per quality-adjusted life-year

—

Countries

Ghana

Contacts

Public ContactMethodius Tuuli

Professor and Chair Women and Infants Hospital of Rhode Island

mtuuli@wihri.org+16785582874

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026