Misoprostol for Second Trimester Termination of Pregnancy

Abortion, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048098
• Other study ID #: atauni9
• 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

• Abortion, Induced

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