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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccal misoprostol | Active Comparator | 400 µg buccal misoprostol per 3 hours |
|
| vaginal misoprostol | Active Comparator | 400 µg vaginal misoprostol per 3 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal misoprostol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Induction to fetal expulsion interval | Time elapsed between administration of the first misoprostol dose until expulsion of the fetus | 15 minutes after fetus delivered |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery within 24 hours | 24 hour | |
| Delivery within 48 hours | 48 hours | |
| Use of additional interventions |
| Measure | Description | Time Frame |
|---|---|---|
| total misoprostol dose | 48 hours | |
| difference in hematocrit measured at entry of the study and after delivery/abortion | at recruitment and 24 hour after abortion | |
| maternal complications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ragıp A AL, MD | Ataturk University Faculty of Medicine | Principal Investigator |
| Ömer E Yapça, MD | Ataturk University Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk Universitesi Araştırma Hastanesi | Erzurum | 25240 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26181087 | Derived | Al RA, Yapca OE. Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):593-598. doi: 10.1097/AOG.0000000000000946. |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
|
| Buccal misoprostol | Drug | 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. |
|
|
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 |
| 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 |
| Rate of complete abortion | 12 hour after fetus and placenta removed |
includes, but not limited blood, transfusions, laparatomy, nausea, vomiting, fever, genital tract injury |
| one weeks |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |