NCT05350670

Brief Summary

Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara. Method: This interventional study included a total of 200 primipara hoping for natural birth. Patients were randomly divided into two groups, one group used routine labor, one group used cold compress and perineal massage. Record the time of second stage of labor, degree of perineal laceration, etc.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

March 9, 2022

Last Update Submit

April 21, 2022

Conditions

Cold Compress

Keywords

the second laborperineal lacerationperineal massage

Outcome Measures

Primary Outcomes (4)

  • the time of second stage of labor

    calculate the time taken for the second stage of labor

    until the end of the second stage of labor

  • Degree of perineal laceration

    The degree of perineal laceration was judged according to the degree of perineal division table

    about 30 minutes after the pregnant woman gives birth

  • Lateral perineal resection rate

    observe whether perineal lateral excision was performed during delivery

    until the end of the second stage of labor

  • Hospitalization days

    observe how long pregnant women stay in the hospital

    up to 2 weeks

Study Arms (2)

perineal massage and cold compress group

EXPERIMENTAL
Behavioral: Perineal massage and cold compress

no intervention group

NO INTERVENTION

Interventions

Perineal massage and cold compressBEHAVIORAL

Using perineal massage and cold compress during the second stage of labor to observe the effect

perineal massage and cold compress group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • want give birth naturally
  • have well developed perineum

You may not qualify if:

  • Abnormal fetal position and head basin
  • Severe obstetric complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 28, 2022

Study Start

April 1, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

April 28, 2022

Record last verified: 2022-04