Plain English Summary
Background and study aims:
Sometimes during childbirth, an episiotomy may have to be performed to help with the delivery of the baby. An episiotomy is a cut that is made in the women’s perineum (the area between the vagina and the anus). This cut makes the vagina opening wider, allowing easier delivery of the baby.
Once the child has been born, the cut is stitched together (sutured) using dissolvable stitches. Three layers of tissue have to be sutured: the vaginal wall, the muscles and the skin. In the months after the birth, some women experience pain during intercourse or even when they are going about their daily lives. Studies in the past have shown that different suture materials and different suture techniques may affect the recovery from a episiotomy. The aim of this study is to compare two often used suture materials, Monocryl and Vicryl rapide, for the suturing of the skin in women with an episiotomy after their first delivery. The patients will be asked about their experiences of pain and assessed for complications in the healing process and comparisons made to see which material is best.
Who can participate
Women over 18 years old who have an episiotomy while giving birth to their first baby.
What does the study involve?
After birth, the vaginal wall and the muscles are sutured in exactly the same way for all participants. They are then randomly allocated to one of two groups. For those in group 1, the skin is sutured using the material Monocryl. For those in group 2, the skin is sutured using Vicryl rapide. They are all asked to fill in questionnaires after 24 hours, 10 days, 6 weeks and 3 months. The results are compared after all questionnaires have been returned.
What are the possible benefits or risks of participants:
Both suture materials are often used for the suturing of the skin. No risks are associated with the participation.
Where is the study run from:
Ikazia Hospital, Rotterdam (Netherlands)
When is the study starting and how long is it expected to run
October 2010 to July 2013
Who is funding the trial
Department of Gynaecology, Ikazia hospital, Rotterdam (Netherlands)
Who is the main contact?
Mr R.G.D.Odijk, MD
Trial website
Contact information
Type
Public
Primary contact
Mr Roeland Odijk
ORCID ID
http://orcid.org/0000-0002-9343-833X
Contact details
Amphia Hospital
Department of Obstetrics and Gynaecology
Langendijk 75
Breda
4819 EV
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ABR 28922
Study information
Scientific title
Suturing of the skin using Monocryl verses suturing of the skin using Vicryl rapide in women with an uncomplicated mediolateral episiotomy after their first delivery
Acronym
MOVE
Study hypothesis
Deliveries are often complicated by perineal trauma. Different suture materials may give differences in complaints when used for suturing. In this trial Monocryl and Vicryl rapide were compared for complaints of pain and dyspareunia and complications such as infections and dehiscence after use for skin repair in episiotomies.
Ethics approval
Ethical Review Committee Scientific Research Rotterdam, 07/10/2010, ref: NL28922.101.10
Study design
Single centre single blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Episiotomy
Intervention
In both arms the episiotomy was sutured as follows:
The vaginal wall was sutured continuously using Vicryl rapide 2-0 from the apex to the hymen. The bulbocavernosus and superficial perineal muscles and subcutaneous tissue were sutured with interrupted stitches using Vicryl 0.
The skin was sutured intracutaneously using Monocryl 3-0 SH in one arm of the trial and using Vicryl rapide 3-0 SH in the other arm of the trial. The first knot was tied in the subcutaneous tissue at the distal end of the episiotomy. From here a continuous intracutaneous suture to the fourchette was made where a knot was tied.
Intervention type
Phase
Drug names
Primary outcome measure
Pain scores as measured by a Visual Analoguous Scale (VAS) when in sitting position at 10 days post partum
Secondary outcome measures
1. Pain, when walking and supine position, using VAS scores at 6 weeks, 3 months
2. Dyspareunia, using the VAS score, measured after 6 weeks, 3 months
3. Wound infections, measured at 10 days, 6 weeks, 3 months
4. Wound dehiscence 10 days, 6 weeks, 3 months
5. Percentage of patients using analgesics, measured at 24 hours, 10 days, 6 weeks, 3 months
6. Percentage of patients that have suture material removed, measured at 10 days, 6 weeks, 3 months
7. Percentage of patients resuming intercourse, measured at 6 weeks, 3 months
Overall trial start date
07/10/2010
Overall trial end date
19/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Episiotomy
2. Primiparous
3. Informed consent
4. Suturing occurs on the delivery room
5. Age>18 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
250
Participant exclusion criteria
1. Immune compromised patient
2. Coagulopathy or thrombocytopenia
3. Existence of ruptures other than ipsilateral vaginal wall rupture that require suturing and may cause additional complaints of pain
4. Haemorrhage requiring fast intervention
5. Inadequate understanding of the Dutch language
Recruitment start date
15/11/2010
Recruitment end date
19/07/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Ikazia Hospital
Montessoriweg 1
Rotterdam
3083 AN
Netherlands
Funders
Funder type
Not defined
Funder name
Ikazia Hospital, Department of Obstetrics and Gynaecology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The intention is to write a full report of the randomised controlled trial with its results and publish it in the summer of 2016.
Intention to publish date
30/06/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list