CompletedNot Applicable

Designed Protocol of Care for Postpartum Perineal Trauma

Egypt100 participantsStarted 2021-10-10

Plain-language 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.

Who can participate

Age range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Postpartum Perineal Trauma Healing

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

Trial details

NCT IDNCT05268276

SponsorAsmaa Abdallah Ahmed Hussein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-15

Results submitted2023-11-05

View on ClinicalTrials.gov More Perineal Injury trials

Plain-language summary

Who can participate

Age range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

What they're measuring

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

Postpartum Perineal Trauma Healing

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

Designed Protocol of Care for Postpartum Perineal Trauma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Designed Protocol of Care for Postpartum Perineal Trauma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria