Misoprostol for Second Trimester Termination of Pregnancy

A Comparison Between Vaginal Misoprostol vs. Buccal Misoprostol For Second Trimester Termination of Pregnancy

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

Study Overview

• Status: Completed
• Conditions: Abortion, Induced
• Intervention / Treatment: Drug: Buccal misoprostol; Drug: Vaginal misoprostol

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Atatürk Üniversitesi Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Buccal misoprostol; 400 µg buccal misoprostol per 3 hours	Drug: Buccal misoprostol; 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.; Other Names: Cytotec
Active Comparator: vaginal misoprostol; 400 µg vaginal misoprostol per 3 hours	Drug: Vaginal 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.; Other Names: Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery within 24 hours		24 hour
Delivery within 48 hours		48 hours
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
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

Other Outcome Measures

Outcome Measure	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	includes, but not limited blood, transfusions, laparatomy, nausea, vomiting, fever, genital tract injury	one weeks

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Ragıp A AL, MD, ATATURK UNIVERSITY FACULTY OF MEDICINE; Study Chair: Ömer E Yapça, MD, ATATURK UNIVERSITY FACULTY OF MEDICINE

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: January 27, 2014
• First Posted (Estimate): January 29, 2014

Study Record Updates

• Last Update Posted (Estimate): January 16, 2015
• Last Update Submitted That Met QC Criteria: January 15, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: misoprostol; Abortion, Induced; Pregnancy Trimester, Second; Labor, Induced
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: atauni9