NCT03473158

Brief Summary

In this study multifetal pregnancy reduction (to twins) will be carried out through a transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days) using 2 methods: mere mechanical disruption against potassium chloride injection. The 2 methods will be compared regarding the efficacy, complications and pregnancy outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

March 9, 2018

Last Update Submit

October 25, 2020

Conditions

Multiple Pregnancy

Keywords

fetal reductionembryo reductionfeticidepotassium chloridemultiple pregnancymultifetal pregnancy

Outcome Measures

Primary Outcomes (1)

  • Success of the procedure

    Number of gestational sacs in which fetal heart activity will stop

    5 minutes after the end of fetal reduction

Secondary Outcomes (4)

  • Duration of the fetal reduction procedure

    5 minutes after the end of the procedure when cessation of fetal heart is confirmed

  • Post-operative vaginal spotting or bleeding

    within the first week of the procedure i.e. from the end of the procedure till 7 days after the procedure

  • Gestational age at birth

    On the same day of delivery

  • Fetal birth weight

    On the same day of delivery

Study Arms (2)

Mechanical

ACTIVE COMPARATOR

fetal reduction will be achieved by mechanical disruption of the fetal heart till asystole is achieved, and may be aided by partial or total suction of the fetus, using suction device attached to the embryo reduction needle

Device: Transvaginal ultrasoundProcedure: Mechanical fetal reduction

Chemical

ACTIVE COMPARATOR

fetal reduction will be achieved by injecting 0.5 mL of potassium chloride (Potassium Chloride® 15% , EIPICO, Egypt) into the cardiac region through the embryo reduction needle

Device: Transvaginal ultrasoundProcedure: Chemical fetal reduction

Interventions

Transvaginal ultrasoundDEVICE

using the 6.5mHz intra-cavitary probe (65EC10EA) of ultrasound machine DP-50 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., P.R.China) to determine the number, site, size and cardiac activity of the fetuses, and monitor the fetal reduction procedure

ChemicalMechanical
Mechanical fetal reductionPROCEDURE

under transvaginal ultrasound guidance, fetal reduction will be achieved by mechanical disruption of the fetal heart till asystole is achieved, and may be aided by partial or total suction of the fetus, using suction device attached to the embryo reduction needle (Cook® Ireland Ltd., Limerick, Ireland)

Also known as: Mechanical disruption
Mechanical
Chemical fetal reductionPROCEDURE

under transvaginal ultrasound guidance, fetal reduction will be achieved by injecting 0.5 mL of potassium chloride (Potassium Chloride® 15% , EIPICO, Egypt) into the cardiac region through the embryo reduction needle (Cook® Ireland Ltd., Limerick, Ireland)

Also known as: Potassium Chloride
Chemical

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with multifetal pregnancy (3 fetuses or more)
  • Pregnant women from 6 weeks to 9 weeks + 6 days

You may not qualify if:

  • Pregnant women with singleton or twin pregnancy
  • Pregnant women before 6 weeks (higher incidence of spontaneous vanishing twin)
  • Pregnant women after 9 weeks + 6 days (the technique is difficult to apply)
  • Pelvic or genital infection
  • Hemorrhagic blood disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Mechanical ThrombolysisPotassium Chloride

Intervention Hierarchy (Ancestors)

TherapeuticsThrombectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Hassan Omar, MD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 22, 2018

Study Start

August 1, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)