Clinical trial NCT05268276: Designed Protocol of Care for Postpartum Perineal Trauma
Official title: The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal Trauma: a Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Injury
Keywords: perineal trauma
outcomes
pospartum
protocol of care
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2022-03-07
Enrollment: 100
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

1. 3rd or 4th degree perineal tear
2. obesity.
3. age more than 40 years
4. having any complications during labor and delivery(e.g., abnormal presentation, obstructed labor or delivered with instrument)
5. having any immediate postnatal complications such as postpartum hemorrhage. \]

Primary outcomes:
measure: Severity of Postpartum Perineal Pain
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
measure: Postpartum Perineal Trauma Healing
timeFrame: one hour after delivery, six hours after delivery, day 7after delivery
Secondary outcomes:
measure: Occurrence of Postpartum Perineal Trauma Infection
timeFrame: day 7 after delivery
measure: Postpartum Difficulty With Performing Functional Activity
timeFrame: 24 hours after delivery, day 3 after delivery, day 5 after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of nursing/Cairo university& Kasr El Aini University Hospital
state: El-manial
Study officials:
affiliation: Cairo University
name: Asmaa Abdallah
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Yousria Ahmed
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Shadia Abdel Kader
role: STUDY_DIRECTOR
References: