Prospective

Elaine Ng

Room 3EF, 3/F, Special block, Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T., Hong Kong

35052745

elaineng@cuhk.edu.hk

research assiatant

Hong Kong

Dr. CHUNG Pui Wah, Jacqueline

1/F, Special Block (Block E), Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T., Hong Kong

35051537

jacquelinechung@cuhk.edu.hk

Associate Professor

Hong Kong

手動真空抽吸術治療早孕期流產後宮腔粘連的發生率

Yes

2016-09-29

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.457

Procedure

MVA is inexpensive, portable, simple to use, convenient, avoids the use of electricity but more importantly can be performed without general anesthesia. The procedure is performed in an outpatient setting with simple oral analgesics or conscious sedation given beforehand. MVA has a high efficacy with similar success rates as electric vacuum aspiration.3 The use of ultrasound guidance during MVA may reduce the discomfort during the introduction, shorten the procedure and ensure that the miscarriage process is complete.

Intrauterine adhesion (IUA) or Asherman’s syndrome is a possible complication after uterine surgery, especially after sharp curettage curette for miscarriages as it destroys the endometrial stratum basalis. IUA can be asymptomatic or it can present with menstrual disturbance like amenorrhea or hypoamenorrhea, dysmenorrhea or with recurrent miscarriages or infertility problems. The presence of intrauterine adhesion may affect future fertility as it may affect the implantation of the embryo. Moreover, it increases the rate of further miscarriages, may lead to abnormal placentation, fetal growth restriction, preterm delivery and post-partum haemorrhage.4 Early detection of IUA is important as early treatment can prevent further complications. The gold standard for the diagnosis of IUA is hysteroscopy.

All women who had MVA or surgical evacuation performed for first trimester delayed or incomplete miscarriage will be invited to participate the study by our research assistant. For those who agree to join the study, an outpatient hysteroscopy will be performed within 3-6 months from their MVA or evacuation procedure by a designated team of experienced gynaecologist. Outpatient hysteroscopy is the gold standard of diagnosing IUA and it is a very common gynaecological procedure in our everyday practice. The hysteroscopy will be performed within day 10 of their last menstrual period and the patient will be advised to use barrier contraception before the procedure. A pregnancy test will be performed before the procedure and any recent coitus recorded.

The outpatient hysteroscopy will be performed using a 2.9mm rigid diagnostic hysteroscopy (Karl Storz, Germany) under aseptic technique and the endometrial cavity will be visualized and assessed systematically. Normal saline will be used for uterine distension. Cervical dilatation is not required and no analgesia will be prescribed. The patient will be discharged from the hospital approximately one hour after the procedure.

The presence of any intrauterine adhesion, the status of bilateral ostias and endometrial cavity and endometrium will berecorded. The severity will be ascertained according to the classification of the American Fertility Society for IUA. 8 If IUA is present, it will be removed during the outpatient procedure.

this is not a drug trial

this is not a drug trial

this is not a drug trial

outpatient hysteroscopy will be performed within 3-6 months from their MVA or evacuation procedure

In a recent meta-analysis, the incidence of intrauterine adhesion is reported to be 18.5% after traditional surgical evacuation.5-6 Up to now, there is limited data to evaluate the incidence of intrauterine adhesion after manual vacuum aspiration for early miscarriages. 7 In this study, we wish to examine the incidence of intrauterine adhesion after manual vacuum aspiration performed for first trimester miscarriages and compared it with that after traditional method of evacuation of uterine cavity by curettage.

this is not a drug trial

this is not a drug trial

this is not a drug trial

outpatient hysteroscopy will be performed within 3-6 months from their MVA or evacuation procedure

All women presenting to our unit with MVA or traditional surgical curettage performed for first-trimester miscarriage or incomplete miscarriage will be invited to join the study.

Women with MVA or surgical curettage performed done for miscarriage gestation > 12 weeks

Women known to have intrauterine adhesion

Subjects with known congenital uterine anomalies or multiple uterine fibroids distorting cavity

Women with known cervical stenosis

Women with recent pelvic inflammatory disease

18

45

Female

Not Applicable

Not Applicable

Open label

Not Applicable

Other

This is not a drug trial

No