Abortion, Induced Clinical Trial
Official title:
A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy
Verified date | January 2015 |
Source | Ataturk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
The purpose of this study is to compare the efficacy of 400 µg vaginal misoprostol per 3 hours to 400 µg buccal misoprostol per 3 hours in second trimester termination of viable pregnancy
Status | Completed |
Enrollment | 130 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - gestational age between 12-24 weeks - live fetus - singleton pregnancy - Bishop score <5 - no uterine contraction Exclusion Criteria: - prostaglandin allergy - a scar in uterus - uterine abnormality - premature rupture of membranes |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | Ataturk Universitesi Arastirma Hastanesi | Erzurum |
Lead Sponsor | Collaborator |
---|---|
Ataturk University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | total misoprostol dose | 48 hours | No | |
Other | difference in hematocrit measured at entry of the study and after delivery/abortion | at recruitment and 24 hour after abortion | No | |
Other | maternal complications | includes, but not limited blood, transfusions, laparatomy, nausea, vomiting, fever, genital tract injury | one weeks | No |
Primary | Induction to fetal expulsion interval | Time elapsed between administration of the first misoprostol dose until expulsion of the fetus | 15 minutes after fetus delivered | No |
Secondary | Delivery within 24 hours | 24 hour | No | |
Secondary | Delivery within 48 hours | 48 hours | No | |
Secondary | Use of additional interventions | the patients who did not delivered within 48 hours will considered as failed induction and will be offered another method of induction/delivery or to continue same protocol. | One week | No |
Secondary | Expected pain before induction and perceived (actual) pain after abortion completed | Expected and perceived pain will be measured by VAS | within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed | No |
Secondary | Rate of complete abortion | 12 hour after fetus and placenta removed | No |
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