Is misoprostol a safe alternative to manual vacuum aspiration in women with incomplete abortions in developing countries?
- Conditions
- First trimester pregnancy failurePregnancy and Childbirth
- Registration Number
- ISRCTN65305620
- Lead Sponsor
- Tanzanian German Program to Support Health (TGPSH) (Tanzania)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 180
1. History of passage of tissue and/or blood and >30 mm endometrial thickness on TransVaginal Sonography (TVS)
2. On TVS an anembryonic gestation or fetal death with an embryonic crown-rump length between 5 and 62 mm without cardiac activity (in case of a Crown-Rump Length [CRL] of 5-9 mm TVS will be repeated after one week to ensure absence of cardiac activity) or an anembryonic gestational sac of 16-45 mm (TVS will be repeated after one week to ensure growth of the gestational sac is <3 mm and exclude a viable pregnancy)
1. On TVS present fetal heart activity, a crown-rump length >62 mm, molar pregnancy or a endometrial thickness less than or equal to 30 mm
2. Fundal height of more than halfway the umbilicus and the symphysis indicating a gestational age >12 weeks
3. Known allergy to prostaglandins
4. Heavy blood loss or a pulse rate of >120/min
5. Axillary temperature of > 38°C or signs of septic abortion such as pus draining from uterus
6. Ectopic pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ltrasonographic endometrium thickness at day 8
- Secondary Outcome Measures
Name Time Method The following will be assessed at day 8: <br>1. Changes in hemoglobin (Hb) level<br>2. Side effects including pain <br>3. Adverse events <br>4. Patients satisfaction and acceptability <br><br>If any problem is observed on day 8, the patient will be reviewed again on day 15 (No review at day 15 if no problem is observed).