NCT03400683

Brief Summary

The Patient are divided into 3 groups group 1 included 50 cases using misoprostol only. group 2 included also 50 cases in which using misoprostol with letrozole. Group3 included also 50 cases in which using misoprostol with Foleys catheter for termination of second trimesteric abortion between 14 and 24 weeks

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

January 8, 2018

Last Update Submit

January 23, 2018

Conditions

Induction of Abortion

Outcome Measures

Primary Outcomes (1)

  • complete evacuation of uterus

    clear endometrial line \< 4 mm in thickness

    24 hours after treatment

Study Arms (3)

misoprostol only group

ACTIVE COMPARATOR

given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses

Drug: Misoprostol

misoprostol with letrozole group

ACTIVE COMPARATOR

group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses

Drug: MisoprostolDrug: Letrozole

misoprotol with Foley's catheter group

ACTIVE COMPARATOR

the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses

Drug: MisoprostolProcedure: Foley's catheter

Interventions

MisoprostolDRUG

200 microgram misoprostol in sublingual every four hours for a maximum of five doses

Also known as: Misotac
misoprostol only groupmisoprostol with letrozole groupmisoprotol with Foley's catheter group
LetrozoleDRUG

15mg( letrozole 2.5mg) on three successive day

Also known as: Femara
misoprostol with letrozole group
Foley's catheterPROCEDURE

transcervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions

Also known as: Urinary catheter
misoprotol with Foley's catheter group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy
  • gestational age between 14 and 24 weeks
  • Fetal death was confirmed by ultrasonic scan
  • Unfavorable cervix using Bishop score for cervical assessment with score less than 5
  • Parity less than 5
  • No uterine contractions

You may not qualify if:

  • Previous uterine scar eg scar for cessarian section
  • Rupture of membranes
  • Chorioamnionitis
  • Placenta previa or low lying placenta.
  • Women with medical disease like DM, coagulopathy or genital infections.
  • Hypersensitivity or contraindications for receiving misoprostol, including:Maternal asthma.Sickle cell disease.Known hypersensitivity to prostaglandins.History of glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

MisoprostolLetrozoleUrinary Catheters

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCathetersEquipment and Supplies

Study Officials

  • Ahmed Maged

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maged

CONTACT

+20201005227404dr_ahmedmaged08@kasralainy.edu.eg

ameer elsherief

CONTACT

ameerelsherief@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

January 1, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

EG(1)