Trial Outcomes & Findings for Designed Protocol of Care for Postpartum Perineal Trauma (NCT NCT05268276)

Last Updated: 2025-03-19

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

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

Results posted on

2025-03-19

Participant Flow

no participants were excluded for the study after enrollment and before assignment to study or control group

Participant milestones

Participant milestones
Measure	Study Group Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman.	Control Group the control group received the routine hospital care (antibiotic every 12 hours and analgesic as needed )
Overall Study STARTED	50	50
Overall Study COMPLETED	47	45
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=50 Participants Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman.	Control Group n=50 Participants The control group received the routine hospital care only	Total n=100 Participants Total of all reporting groups
Age, Customized Age · 18-20 years	12 Participants n=50 Participants	9 Participants n=50 Participants	21 Participants n=100 Participants
Age, Customized Age · 21-30 years	28 Participants n=50 Participants	32 Participants n=50 Participants	60 Participants n=100 Participants
Age, Customized Age · 31-40 years	10 Participants n=50 Participants	9 Participants n=50 Participants	19 Participants n=100 Participants
Sex/Gender, Customized gender · female	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Sex/Gender, Customized gender · male	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
level of education Read &Write	10 Participants n=50 Participants	8 Participants n=50 Participants	18 Participants n=100 Participants
level of education Primary School	3 Participants n=50 Participants	11 Participants n=50 Participants	14 Participants n=100 Participants
level of education Preparatory School	14 Participants n=50 Participants	8 Participants n=50 Participants	22 Participants n=100 Participants
level of education Secondary School	16 Participants n=50 Participants	17 Participants n=50 Participants	33 Participants n=100 Participants
level of education University School	7 Participants n=50 Participants	6 Participants n=50 Participants	13 Participants n=100 Participants
occupation House wife	46 Participants n=50 Participants	45 Participants n=50 Participants	91 Participants n=100 Participants
occupation Working	4 Participants n=50 Participants	5 Participants n=50 Participants	9 Participants n=100 Participants
residence Rural	14 Participants n=50 Participants	16 Participants n=50 Participants	30 Participants n=100 Participants
residence Urban	36 Participants n=50 Participants	34 Participants n=50 Participants	70 Participants n=100 Participants
gravidity Primi gravida	22 Participants n=50 Participants	13 Participants n=50 Participants	35 Participants n=100 Participants
gravidity Gravida 2	17 Participants n=50 Participants	23 Participants n=50 Participants	40 Participants n=100 Participants
gravidity Gravida 3	9 Participants n=50 Participants	9 Participants n=50 Participants	18 Participants n=100 Participants
gravidity Gravida 4	2 Participants n=50 Participants	5 Participants n=50 Participants	7 Participants n=100 Participants
Body Mass Index(BMI) Normal	30 Participants n=50 Participants	33 Participants n=50 Participants	63 Participants n=100 Participants
Body Mass Index(BMI) Over weight	20 Participants n=50 Participants	17 Participants n=50 Participants	37 Participants n=100 Participants
type of perineal trauma Episiotomy	45 Participants n=50 Participants	42 Participants n=50 Participants	87 Participants n=100 Participants
type of perineal trauma Perineal tear	2 Participants n=50 Participants	4 Participants n=50 Participants	6 Participants n=100 Participants
type of perineal trauma both episiotomy and perineal tear	3 Participants n=50 Participants	4 Participants n=50 Participants	7 Participants n=100 Participants

PRIMARY outcome

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

Population: severity of postpartum perineal pain

Outcome measures

Outcome measures
Measure	Study Group n=50 Participants Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman.	Control Group n=50 Participants The control group received the routine hospital care
Severity of Postpartum Perineal Pain one hour after delivery	8.200 score on a scale Standard Deviation 1.21	8.280 score on a scale Standard Deviation 1.27
Severity of Postpartum Perineal Pain six hours after delivery	4.500 score on a scale Standard Deviation 1.87	8.080 score on a scale Standard Deviation 1.17
Severity of Postpartum Perineal Pain 24 hours after delivery	3.880 score on a scale Standard Deviation 2.12	8.020 score on a scale Standard Deviation .97
Severity of Postpartum Perineal Pain day 3 after delivery	2.520 score on a scale Standard Deviation 1.94	7.720 score on a scale Standard Deviation 1.16
Severity of Postpartum Perineal Pain day 5 after delivery	1.260 score on a scale Standard Deviation 2.26	4.700 score on a scale Standard Deviation 2.05
Severity of Postpartum Perineal Pain day 7 after delivery	.7800 score on a scale Standard Deviation 2.15	2.46 score on a scale Standard Deviation 2.64

PRIMARY outcome

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

Population: severity of postpartum perineal pain

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

Outcome measures

Outcome measures
Measure	Study Group n=50 Participants Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman.	Control Group n=50 Participants The control group received the routine hospital care
Postpartum Perineal Trauma Healing day 7 after delivery	.740 score on a scale Standard Deviation 1.41	1.78 score on a scale Standard Deviation 1.56
Postpartum Perineal Trauma Healing one hour after delivery	9.240 score on a scale Standard Deviation 1.91	9.14 score on a scale Standard Deviation 1.94
Postpartum Perineal Trauma Healing 6 hours after delivery	6.460 score on a scale Standard Deviation 2.09	9.04 score on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: day 7 after delivery

Population: postpartum perineal wound infection

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

Outcome measures

Outcome measures
Measure	Study Group n=50 Participants Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman.	Control Group n=50 Participants The control group received the routine hospital care
Occurrence of Postpartum Perineal Trauma Infection infection	7 Participants	13 Participants
Occurrence of Postpartum Perineal Trauma Infection no infection	43 Participants	37 Participants

SECONDARY outcome

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

Population: postpartum difficulties with daily infection

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).

Outcome measures

Outcome measures
Measure	Study Group n=50 Participants Intervention for the study group was carried out according to a designed protocol of care that entails: 1) application of an ice gel pad on perineal trauma for 20 minutes every two hours during the first 24 hours postpartum; 2) performance of pelvic floor exercises (Kegel exercises) five times daily starting from six hours till one week postpartum; and 3) application of warm compresses for 15 minutes three times daily starting after 48 hours and through the first week postpartum. On each intervention, the investigator demonstrated and then redemonstrated with the women. A specially designed booklet (developed previously) that explains each intervention was given to each woman.	Control Group n=50 Participants The control group received the routine hospital care
Postpartum Difficulty With Performing Functional Activity day 3 after delivery · mild difficulty	34 Participants	0 Participants
Postpartum Difficulty With Performing Functional Activity day 3 after delivery · moderate difficulty	6 Participants	16 Participants
Postpartum Difficulty With Performing Functional Activity day 5 after delivery · sever difficulty	2 Participants	5 Participants
Postpartum Difficulty With Performing Functional Activity 24 hours after delivery · no difficulty	0 Participants	0 Participants
Postpartum Difficulty With Performing Functional Activity 24 hours after delivery · mild difficulty	5 Participants	0 Participants
Postpartum Difficulty With Performing Functional Activity 24 hours after delivery · moderate difficulty	37 Participants	17 Participants
Postpartum Difficulty With Performing Functional Activity 24 hours after delivery · sever difficulty	8 Participants	33 Participants
Postpartum Difficulty With Performing Functional Activity day 3 after delivery · no difficulty	9 Participants	0 Participants
Postpartum Difficulty With Performing Functional Activity day 3 after delivery · sever difficulty	1 Participants	34 Participants
Postpartum Difficulty With Performing Functional Activity day 5 after delivery · no difficulty	31 Participants	7 Participants
Postpartum Difficulty With Performing Functional Activity day 5 after delivery · mild difficulty	15 Participants	23 Participants
Postpartum Difficulty With Performing Functional Activity day 5 after delivery · moderate difficulty	2 Participants	15 Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Asmaa Abdallah Ahmed Hussein

Faculty of nursing /cairo university

Phone: 01006961502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place