NCT02013960

Brief Summary

  1. 1.Comparison between the duration of time from the beginning of cervical preparation until abortion, between sublingual misoprostol and the combination of sublingual misoprostol with laminaria for second trimester medical termination of pregnancy (TOP).
  2. 2.Comparison between the adverse event rate following Sublingual misoprostol only vs. Sublingual misoprostol and laminaria given for pregnancy termination.
  3. 3.Comparison between the levels of satisfaction rate of women who underwent pregnancy termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11 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

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

September 16, 2013

Last Update Submit

December 11, 2013

Conditions

Other Abortion

Outcome Measures

Primary Outcomes (1)

  • Duration of time until pregnancy termination

    From the time of receiving the treatment until complete abortion

    Average time 12 hours

Study Arms (2)

Laminaria

EXPERIMENTAL

cytotec and laminaria

Drug: Cytotec

Cytotec

ACTIVE COMPARATOR

Cytotec only

Drug: Cytotec

Interventions

CytotecDRUG

Cytotec medication compared with cytotec and laminaria

Also known as: Misorpristol vs. Misopristol and laimnria
CytotecLaminaria

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Second trimester pregnancy No evidence of chorioamnionitis

You may not qualify if:

  • Allergy to misoprostol. Evidence for infection. Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Campus

Haifa, Israel

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nibal Awad, MD

    Rambam Health Care Campus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 16, 2013

First Posted

December 17, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

IL(1)