Abortion, Induced
Conditions
Keywords
misoprostol, Labor, Induced, Pregnancy Trimester, Second, Abortion, Induced
Brief summary
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
Interventions
DRUGVaginal misoprostol
400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction to fetal expulsion interval | 15 minutes after fetus delivered | Time elapsed between administration of the first misoprostol dose until expulsion of the fetus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery within 48 hours | 48 hours | — |
| Use of additional interventions | One week | 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. |
| Expected pain before induction and perceived (actual) pain after abortion completed | within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed | Expected and perceived pain will be measured by VAS |
| Rate of complete abortion | 12 hour after fetus and placenta removed | — |
| Delivery within 24 hours | 24 hour | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| maternal complications | one weeks | includes, but not limited blood, transfusions, laparatomy, nausea, vomiting, fever, genital tract injury |
| difference in hematocrit measured at entry of the study and after delivery/abortion | at recruitment and 24 hour after abortion | — |
| total misoprostol dose | 48 hours | — |
Countries
Turkey (Türkiye)
Outcome results
None listed