N/A N=100 Randomized Treatment

Designed Protocol of Care for Postpartum Perineal Trauma

Perineal Injury

Bottom Line

View on ClinicalTrials.gov: NCT05268276 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Severity of Postpartum Perineal Pain — 8.200; 8.280; 4.500; 8.080 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 1-perineal ice-gel pad application (Other); 2-performance of pelvic floor exercises (Kegel exercises) (Other); 3- perineal warm compresses application (Other)
Age: Pediatric, Adult
Sex: Female
Sponsor: Asmaa Abdallah Ahmed Hussein
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Severity of Postpartum Perineal Pain	8.200; 8.280; 4.500; 8.080; 3.880; 8.020	—
PRIMARY Postpartum Perineal Trauma Healing	9.240; 9.14; 6.460; 9.04; .740; 1.78	—
SECONDARY Occurrence of Postpartum Perineal Trauma Infection	7; 13; 43; 37	—
SECONDARY Postpartum Difficulty With Performing Functional Activity	0; 0; 5; 0; 37; 17	—

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.

Eligibility Criteria

Inclusion Criteria

Inclusion criteria will be according to the following
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.

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. ]

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05268276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.