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Trial Detail

CUHK_CCRB00529

2016-09-19

Prospective

N/A

Department of Obstetrics and Gynaecology

Department of Obstetrics and Gynaecology

N/A

Not Applicable

Lee Loreta Lai Loi

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

(852) 35052583/ (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 (35052814)

symphorosa@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

A randomised controlled trial on routine episiotomy versus restrictive episiotomy in Chinese nulliparous women

A randomised controlled trial on routine episiotomy versus restrictive episiotomy in Chinese nulliparous women

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

N/A

Hong Kong

Yes

2016-04-30

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC Ref. No.: 2016.081-T

obstetric anal sphincter injury; pelvic floor disorders

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

Interventional

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.

2016-09-20

1200 women

Recruiting

Prevalence of obstetric anal sphincter injury (OASIS; third or fourth degree tear) detected clinically immediately after delivery

Vaginal & rectal examination to assess any vaginal tear, “buttonhole” tear of rectal mucosa, 3rd or 4th degree tear of anal sphincter. Descriptive analysis to study the prevalence of OASIS in each group. Analysis will be performed by intention-to-treat basis. With sub-group analysis if appropriate.

Immediately after delivery of placenta.

Prevalence of obstetric anal sphincter injury (OASIS) detected by endoanal ultrasound at 8 week after delivery

Anal sphincter defect is defined by endoanal US as a discontinuity in the endosonographic image of internal or external sphincter. Descriptive analysis will be used to study the prevalence of OASIS. Analysis will be performed at an intention-to-treat basis. With sub-group analysis if appropriate.

8 weeks after delivery

The changes of pelvic floor disorders after delivery and compare the two groups.

Prevalence of pelvic floor disorders will be studied. Descriptive statistics & Chi-square test for trend will be used. Questionnaires scores will be tested for normality. Non-parametrical data will be transformed if needed. Uni- & multivariate analysis to study risk factor of pelvic floor disorder.

From baseline to 36 weeks of pregnancy, and 8 weeks and 6 months post-delivery

The changes of pelvic floor ultrasound morphology after the delivery, if any, by the perineal ultrasound and compare the two groups.

To study position of pelvic organs, hiatal dimensions, and LAM avulsion by standard way.Student paired t-test or Wilcoxon signed-rank test to study changes in same subject. Unpaired t-test or Mann-Whitney nonparametric test to study indices measured in 2 groups. ANOVA to study means of 3 groups.

From baseline to 36 weeks of pregnancy, and 8 weeks and 6 months post-delivery

Factors contributing to the pelvic floor disorders and the changes in pelvic floor ultrasound morphology.

Chi-square or two-sided Fisher exact test, unpaired t-test or Mann-Whitney test to study indices measured in 2 groups of subjects. Univariate & multivariate analysis will be used to study factors e.g. episiotomy, perineal/vaginal tear, LAM injury, OASIS on pelvic floor disorders or US findings.

Baseline, 36 weeks of pregnancy to 6 months post-delivery

No

2023-04-14

ChiCTR-INR-16009223

2016-09-19

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