NCT02989324

Brief Summary

Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

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, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 7, 2018

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

November 30, 2016

Last Update Submit

February 6, 2018

Conditions

Late Second Trimester Termination of Pregnancy

Outcome Measures

Primary Outcomes (1)

  • induction to expulsion interval

    from time to start induction to time of complete expulsion of product of conception

    24 hours

Study Arms (2)

Vaginal Misoprosto

EXPERIMENTAL

Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section

Drug: MisoprostoL

Misoprostol Plus Foley Catheter

ACTIVE COMPARATOR

Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Drug: MisoprostoLDevice: Foley Catheter

Interventions

MisoprostoLDRUG

Vaginal MisoprostoL

Also known as: CYTOTEC
Misoprostol Plus Foley CatheterVaginal Misoprosto
Foley CatheterDEVICE

Misoprostol Plus Foley Catheter

Misoprostol Plus Foley Catheter

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • IUFD
  • Previous Multiple Cesarean Sections

You may not qualify if:

  • asthma
  • allergy to misoprostol
  • patient refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • ibrahim A el sharkwy, MD

    FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 12, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

February 7, 2018

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)