Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara

April 21, 2022 updated by: Second Affiliated Hospital of Wenzhou Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • want give birth naturally
  • have well developed perineum

Exclusion Criteria:

  • Abnormal fetal position and head basin
  • Severe obstetric complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: perineal massage and cold compress group
Behavioral: Perineal massage and cold compress
Using perineal massage and cold compress during the second stage of labor to observe the effect
No Intervention: no intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time of second stage of labor
Time Frame: until the end of the 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
Time Frame: about 30 minutes after the pregnant woman gives birth
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
Time Frame: until the end of the second stage of labor
observe whether perineal lateral excision was performed during delivery
until the end of the second stage of labor
Hospitalization days
Time Frame: up to 2 weeks
observe how long pregnant women stay in the hospital
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAHoWMU-CR2022-07-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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