Fetal Reduction: Mechanical vs Chemical

Early Fetal Reduction Through a Transvaginal Ultrasound Guided Approach in Multifetal Pregnancies: Mechanical Disruption Against Potassium Chloride Injection. A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Multiple Pregnancy
• Intervention / Treatment: Device: Transvaginal ultrasound; Procedure: Mechanical fetal reduction; Procedure: Chemical fetal reduction

Detailed Description

The incidence of multifetal gestations has increased dramatically over the past several decades. Multiple pregnancies are frequently complicated by maternal and fetal morbidities and mortalities. Data show that the incidence of morbidity and mortality correlate with fetal number. In the United Kingdom, the single embryo transfer policy has reduced the incidence of multifetal gestation. Also, in the United States the ASRM (American society of reproductive medicine) has revised the guidelines to optimize the number of transferred embryos during IVF. However in Egypt, transfer of 3 to 4 embryos is still practiced. The procedure of fetal reduction aims to decrease the occurrence of maternal and perinatal morbidities related to multifetal gestations. It can be carried out transvaginally or transabdominally under ultrasound guidance. It may be done by potassium chloride injection through needle injection, mere mechanical disruption by a needle, or by radiofrequency ablation. In this study multifetal pregnancy reduction will be carried out through transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days), and compare the efficacy, complications and pregnancy outcome using mere mechanical disruption against potassium chloride injection.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mechanical; 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 ultrasound; 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; Procedure: Mechanical fetal reduction; 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); Other Names: Mechanical disruption
Active Comparator: Chemical; 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 ultrasound; 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; Procedure: Chemical fetal reduction; 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); Other Names: Potassium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of the procedure	Number of gestational sacs in which fetal heart activity will stop	5 minutes after the end of fetal reduction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the fetal reduction procedure	Duration in minutes needed for each fetus to be reduced (from time of introduction of embryo reduction needle into the gestational sac till fetal heart activity stops)	5 minutes after the end of the procedure when cessation of fetal heart is confirmed
Post-operative vaginal spotting or bleeding	Number of participants who will develop vaginal spotting or bleeding related to the procedure	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	age of pregnancy in weeks and days at time of delivery	On the same day of delivery
Fetal birth weight	fetal weight in grams at time of delivery	On the same day of delivery

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Riyadh Fertility and Reproductive Health center
• Investigators: Study Director: Hassan Omar, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: feticide; multiple pregnancy; fetal reduction; embryo reduction; potassium chloride; multifetal pregnancy
• Other Study ID Numbers: IVF-001-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No