Designed Protocol of Care for Postpartum Perineal Trauma

NCT05268276 | Completed Results

• 1 other identifier: Asmaa Abdallah Ahmed Hussein
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.To fulfill the aim of this study the following research hypothesis is formulated: H1: Post partum women with perineal trauma who will receive the designed protocol of care will have better perineal trauma outcomes than those who will receive the routine hospital care.Sub-hypothesis 1: Postpartum women with perineal trauma who will receive the designed protocol of care will show better perineal trauma healing than those who will receive the routine hospital care. Sub-hypothesis 2: Postpartum women with perineal trauma who will receive the designed protocol of care will have less perineal pain score than those who will receive the routine hospital care.

Conditions

Perineal Injury

Keywords

perineal trauma; outcomes; pospartum; protocol of care

Outcome Measures

Primary Outcomes (2)

• Severity of Postpartum Perineal Pain

  Postpartum severity of perineal pain will be assessed by Visual Analogue Scale for pain intensity (VAS).It is a self-reported 10 cm horizontal line which represents the subjective estimation of pain intensity. It comprises 0-10-point numerical scale, the two opposite ends representing no pain to severe pain as follows: no pain (0), mild pain (\< 4), moderate pain (4 - \< 8), and sever pain (8-10).

  one hour after delivery, six hours after delivery, 24 hours after delivery, day 3 after delivery, day 5 after delivery, day 7 after delivery

• Postpartum Perineal Trauma Healing

  Postpartum perineal trauma healing will be assessed by standardized Redness,Edema,Echymosis,Discharge,Approximation of sutures( REEDA) scale.The total score ranged from 0 to 15 and categorized as the following; 0 to 2 good wound healing , 3 to 5 moderate wound healing, 6 to 8 mild wound healing, and 9 to 15 poor wound healing . the lower score 0 and the maximum score 15 , as the score decreases it indicate better wound healing

  one hour after delivery, six hours after delivery, day 7after delivery

Secondary Outcomes (2)

• Occurrence of Postpartum Perineal Trauma Infection

  day 7 after delivery

• Postpartum Difficulty With Performing Functional Activity

  24 hours after delivery, day 3 after delivery, day 5 after delivery

Study Arms (2)

study group

EXPERIMENTAL

the study group will recelve adesigned protocol of care that entails three interventions as the following1) Application of ice gel pad on perineal trauma for the first 24 hours post partum 2) Performance of pelvic floor exercises (Kegel exercises) from six hours till one week postpartum 3) Application of warm compresses after 48 hours and through the first week postpartum. The investigator will perform demonstration and then redemonstration by the women on each intervention will be done. A designed booklet (developed previously) that explains each intervention will be given to each woman.

Other: 1-perineal ice-gel pad application; Other: 2-performance of pelvic floor exercises (Kegel exercises); Other: 3- perineal warm compresses application

control group

NO INTERVENTION

The control group will receive the routine hospital care only

Interventions

1-perineal ice-gel pad application OTHER

For the study group Immediately after delivery (within 30 minutes to one hour after delivery), an ice gel pad will be applied to perineal trauma. each gel pad will have fixed standardized diameter (an approximately 5 cm width, 23 cm length, and 1.5 cm thickness) and approved by Egyptian ministry of health. It will be kept in the freezer for 45-60 minutes and will be removed when frozen. Then, it will be wrapped in a sterile pad and applied to cover the perineum and anal region.The investigator will provide a clear and concise information through oral and written instructions about the following; 1) The ice gel pad's purpose, benefits, anticipated effects and how to apply it, 2) Apply the ice gel pad on perineum after birth within 30 minutes to an hour, 3) Instruct the women to apply the ice gel pad for about 20 minutes every two hours during the first 24 hours postpartum only

study group

2-performance of pelvic floor exercises (Kegel exercises) OTHER

women will receive instructions to practice pelvic floor exercises (Kegel exercises) and will be asked to perform these exercises from 6 hours postpartum and continue at home till one week. Before applying the technique, the investigator will teach the women how to recognize the accurate muscle, whereby she imagines holding passing gases or trying to stop the flow of urine midstream at the same time. The women will be taught to insert a clean finger into the vagina before practicing the exercises and if the women feeling pressure around her finger, she is on the right track, . The investigator will perform vaginal examination while the woman is doing the pelvic floor exercises (Kegel exercises) to ensure correct use of muscles. The investigator will instruct the women to continue contracting the muscles for about 5 seconds and then to loosen them for 5 seconds and repeat it for five times each set, perform at least five sets per day

study group

3- perineal warm compresses application OTHER

women will be instructed to apply warm compresses on perineal trauma 48 hours postpartum at home. This will be done by using a clean pad soaked in warm water and squeezed to remove excess water then placed gently on the perineum, the warm compresses will be applied for 15 minutes three times per day (every 8 hours), and water in the bowl will be replaced with every application. Women will be asked to apply warm compresses on perineal trauma from 48 hours postpartum till one week.

study group

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• primiparous or 2nd. multiparaous women with postpartum perineal trauma either episiotomy or perineal tear (first and second degree only)
• age not exceeding 40 years
• body mass index (BMI)within normal 18.5-24.9 kg/m2 or overweight 25-29.9 kg/m2,
• free from any high risk condition affecting perineal trauma healing (e.g., diabetes mellitus or obesity),
• over 37 week gestation
• not having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument),
• not having any immediate postnatal complications such as postpartum hemorrhage.

You may not qualify if:

• rd or 4th degree perineal tear
• obesity.
• age more than 40 years
• having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument)
• having any immediate postnatal complications such as postpartum hemorrhage. \]

Sponsors & Collaborators

• Asmaa Abdallah Ahmed Hussein: lead
• Cairo University: collaborator

Study Sites (1)

faculty of nursing/Cairo university& Kasr El Aini University Hospital

Cairo, El-manial, 11553, Egypt

Location

Results Point of Contact

• Title: Asmaa Abdallah Ahmed Hussein
• Organization: Faculty of nursing /cairo university

asmaaabdallah.cu@cu.edu.eg

01006961502

Study Officials

• Asmaa Abdallah

  Cairo University

  PRINCIPAL INVESTIGATOR

• Yousria Ahmed

  Cairo University

  STUDY DIRECTOR

• Shadia Abdel Kader

  Cairo University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assisstant lecturer at faculty of nursing /cairo university

Model Details: after obtaining the primary and official permission data collection will be carried out through five steps in each group: Recruitment \& randomization; interviewing; initial assessment; intervention; follow up and monitoring. : For the study group the intervention will be according to a designed protocol of care that entails; 1) Application of ice gel pad on perineal trauma for the first 24 hours post partum; 2) Performance of pelvic floor exercises (Kegel exercises) from six hours till one week postpartum; 3) Application of warm compresses after 48 hours and through the first week postpartum. The investigator will perform demonstration and then redemonstration by the women on each intervention will be done. A designed booklet (developed previously) that explains each intervention will be given to each woman.The control group will receive the routine hospital care only

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: March 7, 2022
• Study Start: October 10, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 9, 2023
• Last Updated: March 19, 2025
• Results First Posted: December 27, 2024

Record last verified: 2025-03

Locations

EG (1)