Misoprostol for Second Trimester Termination of Pregnancy

Phase 3CompletedNCT02048098

Ataturk University130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Abortion, Induced

Interventions

Vaginal misoprostolDRUG

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.

Buccal misoprostolDRUG

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.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ataturk Universitesi Araştırma Hastanesi

Erzurum, Turkey (Türkiye)

Outcomes

Primary Outcomes

Induction to fetal expulsion interval

Time elapsed between administration of the first misoprostol dose until expulsion of the fetus

Time frame: 15 minutes after fetus delivered

Secondary Outcomes

Delivery within 24 hours

Time frame: 24 hour

Delivery within 48 hours

Time frame: 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.

Time frame: One week

Expected pain before induction and perceived (actual) pain after abortion completed

Expected and perceived pain will be measured by VAS

Time frame: within 1 hour after randomisation and after 12 hour after complete abortion/placenta removed

Rate of complete abortion

Time frame: 12 hour after fetus and placenta removed

Data from ClinicalTrials.gov

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