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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01541293 -
Intrauterine Lidocaine for Laminaria
|
Phase 1 | |
Completed |
NCT00177333 -
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens
|
Phase 4 | |
Completed |
NCT00370487 -
Comparison of the Safety of First Trimester Abortions Performed by Physicians and Non-Physicians in South Africa and Viet Nam.
|
N/A | |
Completed |
NCT00188071 -
Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen
|
N/A | |
Completed |
NCT02277249 -
Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion
|
N/A | |
Completed |
NCT00386867 -
A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
|
N/A | |
Completed |
NCT00677755 -
Medical Abortion for Emergency Contraception Failure
|
N/A | |
Completed |
NCT02279914 -
Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
|
N/A | |
Completed |
NCT01597726 -
Cervical Priming Before Dilation & Evacuation
|
N/A | |
Completed |
NCT01615731 -
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
|
N/A | |
Completed |
NCT02318212 -
Dilapan-S / Dilasoft E-Registry in Induced Abortion
|
N/A | |
Terminated |
NCT00855842 -
Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
|
N/A | |
Completed |
NCT00330993 -
Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
|
Phase 2 | |
Completed |
NCT00382538 -
Mifepristone and Mid-Trimester Termination of Pregnancy
|
N/A | |
Completed |
NCT03080493 -
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT02485444 -
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion
|
Phase 4 | |
Completed |
NCT00969982 -
Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))
|
N/A | |
Recruiting |
NCT02480543 -
Different Routes of Misoprostol Prior to First Trimester Surgical Abortion
|
Phase 4 | |
Completed |
NCT00870272 -
Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)
|
N/A | |
Completed |
NCT01751087 -
Cervical Preparation Before Dilation and Evacuation
|
N/A |