The Effect of the Modified Perineal Protection Device During Delivery

Knut Haadem

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Perineal Tears.

Treatments: Device: Perineal protection device.

Study type: Interventional

Funder types: Other

Identifiers

NCT02013752

ONLY-HBG (Registry Identifier)

KH-HBG-13

Details and patient eligibility

About

The purpose of this study is to determine whether a modified perineum protection device can reduce tearing during delivery.

Full description

RCT investigation using a modified device during delivery of the baby's head (an earlier model has proved successful) and assess whether the use can decrease delivery tears as measured in length.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vaginal delivery at term (week 36 - 41)

Exclusion criteria

• Age below 18
• Breech delivery
• Not understanding written and oral information

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Perineal device during delivery

Active Comparator group

Description:

Delivery should be managed by using the perineal protection device when the head was crowning and 5-6 cm of it was visible. One part the "tongue" was inserted between the head and the posterior vaginal wall and the "two wings" were held against the perineum and kept in place by the delivery attendant's hand.

Treatment:

Device: Perineal protection device.

Standard care

Other group

Description:

Standard care at delivery: Manual support of the perineum

Treatment:

Device: Perineal protection device.