To explore the efficacy and safety of the Kiwi OmniCup-vacuum extractor for operative vaginal delivery

A multi-center prospective randomized controlled trial on the efficacy and safety of the Kiwi OmniCup-vacuum extractor for operative vaginal delivery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074876

Enrollment

Unknown

Registered

2023-08-18

Start date

2022-01-01

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

operative vaginal delivery

Interventions

Kiwi OmniCup-vacuum extractor group:Kiwi OmniCup-vacuum extractor for operative vaginal delivery

Obstetric forceps group:Obstetric forceps for operative vaginal delivery

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. The cervix is completely dilated. 2. Ruptured fetal membranes 3. Engagement of fetal head. 4. Fetal presentation:head. 5. The fetal position is clear, can confirm that the midwifery device is placed in the correct position 6. The fetal head and the pelvis are commensurate. 7. Satisfactory anesthesia (spinal anesthesia is better than perineal nerve block anesthesia). 8. Empty urinary bladder. 9. Complete facilities and sufficient reserve personnel 10.Signed standardized informed consent form.

Exclusion criteria

Exclusion criteria: 1.The fetal head drops nates, and the birth canal space is not enough. 2.The fetal head is not connected. 3. Abnormal fetal position, including breech position, and facial position 4.The fetal membrane is intact. 5.The cervix was not fully dilated. 6. Preterm infants at <34 weeks. 7. Abnormal fetal coagulation function is known.

Design outcomes

Primary

Measure	Time frame
efficacy rates of operative vaginal delivery;the safety of operative vaginal delivery;	—

Secondary

Measure	Time frame
haemoglobin;	—

Countries

China

Contacts

Public ContactWang ZIlian

The First Affiliated Hospital of Sun Yat-sen University

wangzil@mail.sysu.edu.cn+86 136 0288 5248

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026