NCT05268276

Designed Protocol of Care for Postpartum Perineal Trauma

Completed NA Results posted Last updated 19 March 2025

What this trial tests

NA trial testing 1-perineal ice-gel pad application in Perineal Injury in 100 participants. Completed in 9 March 2023.

Timeline

10 October 2021

Primary endpoint
15 March 2022

9 March 2023

Quick facts

Lead sponsor	Asmaa Abdallah Ahmed Hussein
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	10 October 2021
Primary completion	15 March 2022
Estimated completion	9 March 2023
Sites	1 location across Egypt

Drugs / interventions tested

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

Conditions studied

• Perineal Injury — all drugs for Perineal Injury →

Sponsor

Asmaa Abdallah Ahmed Hussein

Who can join

Under 40, female only, with Perineal Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Severity of Postpartum Perineal Pain Primary · 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).

one hour after delivery

Group	Value	95% CI
Study Group	8.200	± 1.21
Control Group	8.280	± 1.27

six hours after delivery

Group	Value	95% CI
Study Group	4.500	± 1.87
Control Group	8.080	± 1.17

24 hours after delivery

Group	Value	95% CI
Study Group	3.880	± 2.12
Control Group	8.020	± .97

day 3 after delivery

Group	Value	95% CI
Study Group	2.520	± 1.94
Control Group	7.720	± 1.16

day 5 after delivery

Group	Value	95% CI
Study Group	1.260	± 2.26
Control Group	4.700	± 2.05

day 7 after delivery

Group	Value	95% CI
Study Group	.7800	± 2.15
Control Group	2.46	± 2.64

Postpartum Perineal Trauma Healing Primary · 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

one hour after delivery

Group	Value	95% CI
Study Group	9.240	± 1.91
Control Group	9.14	± 1.94

6 hours after delivery

Group	Value	95% CI
Study Group	6.460	± 2.09
Control Group	9.04	± 1.88

day 7 after delivery

Group	Value	95% CI
Study Group	.740	± 1.41
Control Group	1.78	± 1.56

Occurrence of Postpartum Perineal Trauma Infection Secondary · 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

Group	Value	95% CI
Study Group	7
Control Group	13
Study Group	43
Control Group	37

Postpartum Difficulty With Performing Functional Activity Secondary · 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)

24 hours after delivery

Group	Value	95% CI
Study Group	0
Control Group	0
Study Group	5
Control Group	0
Study Group	37
Control Group	17
Study Group	8
Control Group	33

day 3 after delivery

Group	Value	95% CI
Study Group	9
Control Group	0
Study Group	34
Control Group	0
Study Group	6
Control Group	16
Study Group	1
Control Group	34

day 5 after delivery

Group	Value	95% CI
Study Group	31
Control Group	7
Study Group	15
Control Group	23
Study Group	2
Control Group	15
Study Group	2
Control Group	5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.