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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02048098
Other study ID # atauni9
Secondary ID
Status Completed
Phase Phase 3
First received January 24, 2014
Last updated January 15, 2015
Start date January 2014
Est. completion date December 2014

Study information

Verified date January 2015
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Ataturk Universitesi Arastirma Hastanesi Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

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
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