Designed Protocol of Care for Postpartum Perineal Trauma

Not Applicable

Completed

Conditions: Perineal Injury

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

Registration Number: NCT05268276

Lead Sponsor: Asmaa Abdallah Ahmed Hussein

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.

Detailed Description: This randomized controlled trial will be conducted to test the effect of designed protocol of care that include; perineal ice-gel pad application for the first 24 hours after delivery, performance of pelvic floor exercises (Kegel exercises) for six hours till one week postpartum and perineal warm compresses application from 48 hours till one week postpartum on the outcomes of postpartum perineal trauma .The study will be conducted on (100) postpartum women with normal spontaneous vaginal delivery and having postpartum perineal trauma that randomly assigned to either study group (50) women or control group (50) women.The study will be conducted at postpartum ward of emergency department for labor and delivery in Obstetrics and Gynecology Hospital at Kasr El Aini University Hospital affiliated to Cairo University.Required data will be collected by using 5 tools: A) Structured interview schedule; B) Visual Analogue Scale for pain intensity(VAS); C) Visual Analogue Scale (VAS) for rating functional activities; D) Standardized REEDA scale; and E) Postpartum follow up sheet. the primary official permission will be obtained from the research ethics committee of faculty of nursing, Cairo University to approve the tools and the study. An official permission will be granted from the hospital administrative personnel in the recommended setting to collect the data. Then, data collection will be carried out through five steps in each group: Recruitment \& randomization; interviewing; initial assessment; intervention; follow up and monitoring.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

3rd 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. ]

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	2-performance of pelvic floor exercises (Kegel exercises)	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.
study group	1-perineal ice-gel pad application	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.
study group	3- perineal warm compresses application	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.

Primary Outcome Measures

Name	Time	Method
Severity of Postpartum Perineal Pain	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 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).
Postpartum Perineal Trauma Healing	one hour after delivery, six hours after delivery, day 7after delivery	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

Secondary Outcome Measures

Name	Time	Method
Occurrence of Postpartum Perineal Trauma Infection	day 7 after delivery	Postpartum perineal trauma infection will be assessed by standardized REEDA scale. the score ranged from 0-15 , score from 0 to 2 indicates no wound infection,while from 3-15 indicates wound infection
Postpartum Difficulty With Performing Functional Activity	24 hours after delivery, day 3 after delivery, day 5 after delivery	postpartum difficulty with performing functional activity as (turning/rolling in bed, getting out of bed, sitting, walking, defecation and urination) will be assessed using Visual Analogue Scale for rating functional activity.The scoring for each activity will be as follows: no difficulty (0), mild difficulty (\< 4), moderate difficulty (4 - \<8), and sever difficulty (8-10). The total score will be recorded (0-60 point), the lowest score (0) indicate no difficulties and the maximum score (60) indicate maximum difficulty. The total score will be interpreted as the following no difficulties (0), Mild difficulties (1 - \< 24), Moderate difficulties (24 - \< 48), Sever difficulties (48-60).