NCT02048098

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 24, 2014

Last Update Submit

January 15, 2015

Conditions

Abortion, Induced

Keywords

misoprostolLabor, InducedPregnancy Trimester, SecondAbortion, Induced

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Delivery within 24 hours

    24 hour

  • Delivery within 48 hours

    48 hours

  • Use of additional interventions

    One week

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

    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 Outcomes (3)

  • 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

    one weeks

Study Arms (2)

Buccal misoprostol

ACTIVE COMPARATOR

400 µg buccal misoprostol per 3 hours

Drug: Buccal misoprostol

vaginal misoprostol

ACTIVE COMPARATOR

400 µg vaginal misoprostol per 3 hours

Drug: Vaginal misoprostol

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.

Also known as: Cytotec
vaginal misoprostol
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.

Also known as: Cytotec
Buccal misoprostol

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • gestational age between 12-24 weeks
  • live fetus
  • singleton pregnancy
  • Bishop score \<5
  • no uterine contraction

You may not qualify if:

  • prostaglandin allergy
  • a scar in uterus
  • uterine abnormality
  • premature rupture of membranes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk Universitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 26181087DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Ragıp A AL, MD

    Ataturk University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Ömer E Yapça, MD

    Ataturk University Faculty of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 29, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

TU(1)