IUCD Complication
Conditions
Brief summary
The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.
Detailed description
According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 10 weeks based on the last menstrual period Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of complete abortion
Interventions
total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
DRUGMisoprostol
Misoprosrol 800mcg will be given to all patients for induction of abortion
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind randomized parallel assign controlled trial
Intervention model description
double blind randomized parallel assign controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Gestational age less than 70 days gestation (\<10 wks) * Hemoglobin \>10 g/dL. * BMI between 18.5 kg/m2 and 30 kg/m2. * Missed abortion
Exclusion criteria
* Molar pregnancy. * Fibroid uterus. * Uterine anomalies. * Coagulopathy. * Medical disorder that contraindicate induction of abortion (e.g. heart failure). * Previous attempts for induction of abortion in the current pregnancy. * Allergy to misoprostol or letrozole. * Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with complete abortion | 12 hours | number of patients with complete abortion |
| time from induction to abortion | 12 hours | time from induction to abortion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of the women will undergo dilatation and curettage after failed medical induction of abortion | 12 hours | number of the women will undergo dilatation and curettage after failed medical induction of abortion |
Countries
Egypt
Contacts
Primary Contacthany f Sallam, md
Backup Contactnahla waer Shady
Outcome results
None listed