First trimester pregnancy failure Pregnancy and Childbirth First trimester pregnancy failure
Conditions
Interventions
Misoprostol 600 microgram 3 doses (one dose every 4 hours) sublingually versus MVA
Sponsors
Tanzanian German Program to Support Health (TGPSH) (Tanzania)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ultrasonographic endometrium thickness at day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at day 8: 1. Changes in hemoglobin (Hb) level 2. Side effects including pain 3. Adverse events 4. Patients satisfaction and acceptability 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). | — |
Countries
Tanzania
Outcome results
None listed