Evaluation of the effect of amniotic layer transplantation of embryonic membranes on pain, infection, repair and opening of large episiotomies
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Excel software rand function was used for randomization
Settings and conduct
Umm Al-Banin Hospital in Mashhad In this project, healthy women who have given birth have been expanded for episiotomy (ie the length of the site in the vaginal mucosa is more than 5 cm and the depth of the episiotomy site is more than 3 cm. The study method and its objectives and obtaining the consent of the participants in the study are included in the plan. To hide the allocation, closed-door envelopes are used.
Participants/Inclusion and exclusion criteria
Healthy women without specific diseases
Absence of fever and infection during childbirth
Need an episiotomy to deliver
Exclusion criteria:
Use of instrumental delivery,
Prolonged rupture of the bladder
Long hospital stay longer than 24 hours
Multiple examinations and fever
Intervention groups
Intervention group: Newly delivered women will need an amniotic layer transplant for fetal membranes with the need for an episiotomy for labor whose episiotomy has been expanded.
Control group (s)
Newly delivered women will need an episiotomy to give birth if their episiotomy is enlarged and they will be given routine treatment.
Main outcome variables
Pain intensity at the episiotomy repair site using a pain ruler for up to 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N54
Registration date:2022-07-03, 1401/04/12
Registration timing:prospective
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Amniotic membrane graft of the fetal membrane on pain, infection, and repair of large episiotomy
Public title
The Effect of Amniotic membrane graft of the fetal membrane on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Healthy women without specific diseases
Absence of fever and infection during childbirth
Need an episiotomy to deliver
Expansion of the episiotomy
Exclusion criteria:
Use of instrumental delivery
Prolonged rupture of the bladder
Multiple examinations and fever
Long hospital stay longer than 24 hours
Withdrawal from study during childbirth
Failure to refer to postpartum care are among the factors excluded from the study
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation block method was used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequence was performed using random allocation software and block size four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied.
Blinding (investigator's opinion)
Double blinded
Blinding description
Closed-door envelopes are used to conceal the allocation. According to the order of arrival of the research units, the envelopes are opened in order and the assigned group is revealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
12345
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.039
Health conditions studied
1
Description of health condition studied
Complications of labour and delivery
ICD-10 code
ICD-10 code description
Complications of labour and deliveryPerineal laceration during delivery
Primary outcomes
1
Description
Severe pain at the site of episiotomy repair
Timepoint
Up to 24 hours after the intervention
Method of measurement
Using a pain ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Newly delivered women will need an amniotic membrane transplant for fetuses who need an enlarged episiotomy to give birth.
Category
Treatment - Other
2
Description
Control group: Newly delivered women will need to undergo an episiotomy for labor whose episiotomy has been expanded and will undergo routine treatment.