Clinical Trials Logo
  1. Home
  2. Abortion, Induced
  3. NCT02279914

Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

Abortion, Induced Clinical Trial

Official title:
Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

Clinical Trial Summary

This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg administered 1.5 hours before D&E. Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design. Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability

Clinical Trial Description

The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02279914
Study type Interventional
Source Planned Parenthood of Greater New York
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date August 2016
View Details
See also
  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 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 NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3
Completed NCT01751087 - Cervical Preparation Before Dilation and Evacuation N/A