The MOVE-trial: monocryl versus vicryl rapide for skin repair of episiotomies: a randomised controlled trial

ISRCTN ISRCTN29869308
DOI https://doi.org/10.1186/ISRCTN29869308
Secondary identifying numbers ABR 28922
Submission date
15/04/2016
Registration date
20/04/2016
Last edited
19/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Roeland Odijk
Public

Amphia Hospital, Department of Obstetrics and Gynaecology
Langendijk 75
Breda
4819 EV
Netherlands

ORCiD logoORCID ID 0000-0002-9343-833X

Study information

Study designSingle centre single blinded randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSuturing of the skin using Monocryl verses suturing of the skin using Vicryl rapide in women with an uncomplicated mediolateral episiotomy after their first delivery
Study acronymMOVE
Study objectivesDeliveries 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(s)Ethical Review Committee Scientific Research Rotterdam, 07/10/2010, ref: NL28922.101.10
Health condition(s) or problem(s) studiedEpisiotomy
InterventionIn 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 typeProcedure/Surgery
Primary outcome measurePain scores as measured by a Visual Analoguous Scale (VAS) when in sitting position at 10 days post partum
Secondary outcome measures1. 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 study start date07/10/2010
Completion date19/07/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants250
Total final enrolment250
Key inclusion criteria1. Episiotomy
2. Primiparous
3. Informed consent
4. Suturing occurs on the delivery room
5. Age>18 years
Key exclusion criteria1. 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
Date of first enrolment15/11/2010
Date of final enrolment19/07/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Ikazia Hospital
Montessoriweg 1
Rotterdam
3083 AN
Netherlands

Sponsor information

Ikazia Hospital, Department of Obstetrics and Gynaecology
Hospital/treatment centre

Montessoriweg 1
Rotterdam
3083 AN
Netherlands

ROR logo "ROR" https://ror.org/01abkkw91

Funders

Funder type

Not defined

Ikazia Hospital, Department of Obstetrics and Gynaecology

No information available

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe intention is to write a full report of the randomised controlled trial with its results and publish it in the summer of 2016.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/10/2017 30/11/2020 Yes No
Dataset 16/10/2017 19/05/2023 No No

Editorial Notes

19/05/2023: Dataset added.
30/11/2020: Publication reference and total final enrolment added.