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Trial History Detail on 2011-04-01

CUHK_CCT00168

2008-08-28

Prospective

Nil

Nil

Nil

Nil

Kong Wing Shan Grace

e-mail gracekong@cuhk.edu.hk

Kong Wing Shan Grace

e-mail gracekong@cuhk.edu.hk

The Physical and Psychological Outcomes of Expectant Management, Surgical Evacuation or Medical Evacuation with Single Dose 800 mcg Vaginal Misoprostol for Women with First Trimester Miscarriage in a Randomized Controlled Trial

Nil

Yes

2008-08-11

Women with first trimester miscarriage

Other

Drug & Procedure

Expectant management, Surgical evacuation or Medical evacuation with single dose 800 mcg Misoprostol

2 weeks

Expectant management, Surgical evacuation or Medical evacuation with single dose 800 mcg Misoprostol

Inclusion Criteria: (i) ≥18 years old HK citizen (ii) Good past health; (iii) Gestation age ≤13 weeks; (iv) Ultrasound confirmed the diagnosis of miscarriage: (a) intrauterine gestational sac with mean sac diameter of ≥2cm without fetal pole; (b) presence of fetal pole with no cardiac pulsation; (c) the gestational sac was <2cm with no interval growth or persistent absence of fetal cardiac pulsation on rescanning 7 to 10 days later (v) Incomplete miscarriage which is supported by opened endocervical os and ultrasound findings of an endometrial echo showing mixed echogenicity.

Exclusion Criteria: (i) Women had complete miscarriage which was supported by an intrauterine dimension measuring <11cm2 (sagittal plus transverse plane) on ultrasound (ii) Severe blood loss, sepsis (iii) Known allergy to prostaglandin or their analogues (iv) Any reason that the attending clinician thinks that may make the patient unsuitable for misoprostol administration

Randomized

Active

Single-blind

Parallel

2008-09-01

180

Unknown

1. To assess the complete miscarriage rates and its complications of each treatment modalities 2. To determine the predictive factors for successful outcome of currently acceptable forms of treatment 3. To assess the acceptance and satisfaction of treatment 4. To assess the psychological outcomes of currently acceptable forms of treatment, with a focus the miscarrying woman's experience 5. To assess the women's preference of currently acceptable forms of treatment 6. To assess the psychological impact of father of pregnancy during treatment

Nil

No

2013-01-21

ChiCTR-TRC-09000725

2010-05-04


Yes

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