Abortion, Missed
Conditions
Brief summary
This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
Detailed description
In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.
Interventions
DRUGIsonicotinic Acid
Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
DRUGPlacebo
Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
DRUGMisoprostol
Drug: Misoprostol 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
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind randomized controlled study
Intervention model description
double blind randomized controlled study
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 * previous one or more cesarean deliveries
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 INH.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| induction to abortion time | 9 hours | induction to abortion time |
| number of patient with complete abortion | 9 hours | number of patient with complete abortion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patient need for surgical evacuation of the products of conception | 12 hours | number of patient need for surgical evacuation of the products of conception |
Countries
Egypt
Contacts
Primary Contacthany f Sallam, md
Backup Contactnahla w Shady, md
Outcome results
None listed