Prospective

Lee Loreta Lai Loi

1E, Department of Obstetrics and Gynaecology,
Prince of Wales Hospital,
Shatin, N.T.,
Hong Kong SAR

(852) 2632 6250/ (852) 6683 9684

loretalee@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

CHAN Symphorosa Shing Chee

1E, Department of Obstetrics and Gynaecology,
Prince of Wales Hospital,
Shatin, N.T.,
Hong Kong SAR

852 (26322810)

symphorosa@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

首次陰道產的華人婦女常規性對比約束性外陰切開助產之隨機研究

Yes

2016-04-30

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC Ref. No.: 2016.081-T

Procedure

Restrictive episiotomy:
For the restrictive episiotomy group, women will not receive episiotomy unless with the decision of the midwife or obstetrician conducting the delivery believes that an episiotomy is necessary for either maternal or fetal indication. In case, episiotomy is needed, a mediolateral episiotomy should be made in the same way as described above. Apart from this, the delivery will also be conducted in the usual manner, same as the “Routine episiotomy group”. The fetal head will be kept flexed by midwife or obstetrician applying gentle pressure on the emerging occiput in a downward direction towards the perineum. Their index, middle, ring and little fingers of the left hand will be closed and place on the infant’s occiput to prevent extension during the delivery of fetal head until it is crowned. Simultaneously, the right hand will be placed on the perineum with the index finger and thumb forming a “U” shape during the crowning process to prevent perineal or vaginal damage. In case, episiotomy is performed, the indication will be recorded, namely rigid perineum, big baby, fetal distress, or others.

N/A

N/A

N/A

N/A

Routine episiotomy:
At the time of fetal head crowning, local analgesia will be injected to the left side of perineum starting from the posterior fourchette and along the intended left mediolateral episiotomy site. Women will then receive a mediolateral episiotomy by the attending midwife or obstetrician at the time of fetal head crowning.The mediolateral episiotomy will be made at the left side of perineum using a pair of Mayo-curved scissors with the curve tip facing upward by midwife or the attending obstetrician who will conduct the delivery. This is the same practice for other women managed in our department. The mediolateral episiotomy should be made 60 degrees from midline. Then the delivery will be conducted in the usual manner, the ‘hands on’ method. The fetal head will be kept flexed by midwife or obstetrician applying gentle pressure on the emerging occiput in a downward direction towards the perineum. Their index, middle, ring and little fingers of the left hand will be closed and place on the infant’s occiput to prevent extension during the delivery of fetal head until it is crowned. Simultaneously, the right hand will be placed on the perineum with the index finger and thumb forming a “U” shape during the crowning process to prevent perineal or vaginal damage.

N/A

N/A

N/A

N/A

1. Chinese nulliparous women with singleton pregnancy who present at the first trimester to the antenatal clinic

2. Willing to give written consent to participate in the study

1. Non-Chinese ethnicity

2. Age less than 18 years old

3. Mental incapacity

4. Women with multiple pregnancy or multiparous

5. Previous medical history that is contraindicated for vaginal delivery

6. Refuse to participate in the study

18

N/A

Female

Randomized

Permuted-block randomisation at ratio of 2:2 using a block size of 4.

Active

Single-blind

Investigator/research team

Parallel

Other

N/A

To compare routine and restrictive episiotomy on pelvic floor and perineum of Chinese nulliparous women. Symptoms of pelvic floor disorders, health-related QoL, and sexual function will be assessed. Translabial and endoanal ultrasound will be used to assess pelvic floor and anal sphincter.

No